{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "197568",
      "product_res_number": "Z-1108-2023",
      "event_date_initiated": "2022-12-22",
      "event_date_posted": "2023-02-09",
      "recall_status": "Open, Classified",
      "res_event_number": "91359",
      "product_code": "PFV",
      "product_description": "The Covera Vascular Covered Stent is a flexible, self-expanding endoprothesis comprised of ePTFE encapsulating a nitinol stent framework.  The inner lumen of the covered stent is carbon impregnated.",
      "code_info": "Catalog Numbers/UDI Codes/Lot_Serial Numbers:\nAVFM06040\n(01)00801741106422(17)230806(10)ANFV0313\n(01)00801741106422(17)231105(10)ANFY0615\n(01)00801741106422(17)231112(10)ANFY1670\nANFV0313\nANFY0615\nANFY1670\n\nAVFM06080\t\t\n(01)00801741106446(17)231001(10)ANFX0083\nANFX0083\n\nAVFM06100\n(01)00801741106453(17)230625(10)ANFT3586\n(01)00801741106453(17)230924(10)ANFW3143\nANFT3586\nANFW3143\n\nAVFM07040\n(01)00801741106460(17)230618(10)ANFT2594\n(01)00801741106460(17)230728(10)ANFU3611\n(01)00801741106460(17)230804(10)ANFV0172\n(01)00801741106460(17)231101(10)ANFY0004\n(01)00801741106460(17)231105(10)ANFY0616\nANFT2594\nANFU3611\nANFV0172\nANFY0004\nANFY0616\n\t\nAVFM07060\n(01)00801741106477(17)230611(10)ANFT1469\n(01)00801741106477(17)230618(10)ANFT2644\n(01)00801741106477(17)230702(10)ANFU0185\n(01)00801741106477(17)230709(10)ANFU1105\n(01)00801741106477(17)230722(10)ANFU2677\n(01)00801741106477(17)230804(10)ANFV0168\n(01)00801741106477(17)230809(10)ANFV0764\n(01)00801741106477(17)230809(10)ANFV0844\n(01)00801741106477(17)231007(10)ANFX1081\n(01)00801741106477(17)231026(10)ANFX3588\n(01)00801741106477(17)231029(10)ANFX4098\nANFT1469\nANFT2644\nANFU0185\nANFU1105\nANFU2677\nANFV0168\nANFV0764\nANFV0844\nANFX1081\nANFX3588\nANFX4098\n\nAVFM07080\n(01)00801741106484(17)230611(10)ANFT1470\n(01)00801741106484(17)230722(10)ANFU2678\n(01)00801741106484(17)231103(10)ANFY0162\n(01)00801741106484(17)231105(10)ANFY0655\nANFT1470\nANFU2678\nANFY0162\nANFY0655\n\nAVFM07100\n(01)00801741106491(17)230722(10)ANFU2681\n(01)00801741106491(17)230917(10)ANFW2013\n(01)00801741106491(17)231029(10)ANFX4135\n(01)00801741106491(17)231112(10)ANFY1672\nANFU2681\nANFW2013\nANFX4135\nANFY1672\n\nAVFM08040\n(01)00801741106507(17)230604(10)ANFT0451\n(01)00801741106507(17)230611(10)ANFT1471\n(01)00801741106507(17)230618(10)ANFT2595\n(01)00801741106507(17)230702(10)ANFU0186\n(01)00801741106507(17)230716(10)ANFU2274\n(01)00801741106507(17)230721(10)ANFU2533\n(01)00801741106507(17)230804(10)ANFV0169\n(01)00801741106507(17)230804(10)ANFV0174\n(01)00801741106507(17)230809(10)ANFV0765\n(01)00801741106507(17)230813(10)ANFV0992\n(01)00801741106507(17)231007(10)ANFX1082\n(01)00801741106507(17)231008(10)ANFX1455\n(01)00801741106507(17)231101(10)ANFY0003\n(01)00801741106507(17)231105(10)ANFY0617\n(01)00801741106507(17)231216(10)ANFZ1835\nANFT0451\nANFT1471\nANFT2595\nANFU0186\nANFU2274\nANFU2533\nANFV0169\nANFV0174\nANFV0765\nANFV0992\nANFX1082\nANFX1455\nANFY0003\nANFY0617\nANFZ1835\n\nAVFM08060\n(01)00801741106514(17)230604(10)ANFT0452\n(01)00801741106514(17)230611(10)ANFT1472\n(01)00801741106514(17)230618(10)ANFT2645\n(01)00801741106514(17)230702(10)ANFU0160\n(01)00801741106514(17)230702(10)ANFU0183\n(01)00801741106514(17)230709(10)ANFU1073\n(01)00801741106514(17)230722(10)ANFU2679\n(01)00801741106514(17)230730(10)ANFU3900\n(01)00801741106514(17)230804(10)ANFV0170\n(01)00801741106514(17)230806(10)ANFV0247\n(01)00801741106514(17)230809(10)ANFV0766\n(01)00801741106514(17)230809(10)ANFV0841\n(01)00801741106514(17)230813(10)ANFV0990\n(01)00801741106514(17)230917(10)ANFW2014\n(01)00801741106514(17)230924(10)ANFW3144\n(01)00801741106514(17)231001(10)ANFX0075\n(01)00801741106514(17)231007(10)ANFX1080\n(01)00801741106514(17)231008(10)ANFX1456\n(01)00801741106514(17)231028(10)ANFX3740\n(01)00801741106514(17)231029(10)ANFX4099\n(01)00801741106514(17)231111(10)ANFY1507\n(01)00801741106514(17)231112(10)ANFY1673\nANFT0452\nANFT1472\nANFT2645\nANFU0160\nANFU0183\nANFU1073\nANFU2679\nANFU3900\nANFV0170\nANFV0247\nANFV0766\nANFV0841\nANFV0990\nANFW2014\nANFW3144\nANFX0075\nANFX1080\nANFX1456\nANFX3740\nANFX4099\nANFY1507\nANFY1673\n\nAVFM08080\n(01)00801741106521(17)230604(10)ANFT0469\n(01)00801741106521(17)230611(10)ANFT1473\n(01)00801741106521(17)230618(10)ANFT2646\n(01)00801741106521(17)230716(10)ANFU2244\n(01)00801741106521(17)230723(10)ANFU2724\n(01)00801741106521(17)230723(10)ANFU2984\n(01)00801741106521(17)230903(10)ANFW0161\n(01)00801741106521(17)230917(10)ANFW2015\n(01)00801741106521(17)230924(10)ANFW3145\n(01)00801741106521(17)231008(10)ANFX1457\n(01)00801741106521(17)231015(10)ANFX2040\n(01)00801741106521(17)231015(10)ANFX2271\n(01)00801741106521(17)231105(10)ANFY0618\nANFT0469\nANFT1473\nANFT2646\nANFU2244\nANFU2724\nANFU2984\nANFW0161\nANFW2015\nANFW3145\nANFX1457\nANFX2040\nANFX2271\nANFY0618\n\nAVFM08100\n(01)00801741106538(17)230604(10)ANFT0489\n(01)00801741106538(17)230709(10)ANFU1074\n(01)00801741106538(17)230722(10)ANFU2680\n(01)00801741106538(17)230823(10)ANFV2290\n(01)00801741106538(17)230924(10)ANFW3146\n(01)00801741106538(17)231101(10)ANFY0002\n(01)00801741106538(17)231105(10)ANFY0619\n(01)00801741106538(17)231216(10)ANFZ1834\nANFT0489\nANFU1074\nANFU2680\nANFV2290\nANFW3146\nANFY0002\nANFY0619\nANFZ1834\n\nAVFM09040\n(01)00801741106545(17)230604(10)ANFT0470\n(01)00801741106545(17)230611(10)ANFT1474\n(01)00801741106545(17)230618(10)ANFT2596\n(01)00801741106545(17)230721(10)ANFU2535\n(01)00801741106545(17)230823(10)ANFV2291\n(01)00801741106545(17)230924(10)ANFW3147\n(01)00801741106545(17)231015(10)ANFX2042\n(01)00801741106545(17)231015(10)ANFX2272\nANFT0470\nANFT1474\nANFT2596\nANFU2535\nANFV2291\nANFW3147\nANFX2042\nANFX2272\n\nAVFM09060\n(01)00801741106552(17)230604(10)ANFT0487\n(01)00801741106552(17)230611(10)ANFT1475\n(01)00801741106552(17)230618(10)ANFT2597\n(01)00801741106552(17)230628(10)ANFT3760\n(01)00801741106552(17)230702(10)ANFU0161\n(01)00801741106552(17)230709(10)ANFU1106\n(01)00801741106552(17)230723(10)ANFU2985\n(01)00801741106552(17)230728(10)ANFU3452\n(01)00801741106552(17)230730(10)ANFU3901\n(01)00801741106552(17)230809(10)ANFV0842\n(01)00801741106552(17)230817(10)ANFV1547\n(01)00801741106552(17)230917(10)ANFW2016\n(01)00801741106552(17)230924(10)ANFW3148\n(01)00801741106552(17)231001(10)ANFX0112\n(01)00801741106552(17)231012(10)ANFX1798\n(01)00801741106552(17)231015(10)ANFX2273\n(01)00801741106552(17)231105(10)ANFY0620\n(01)00801741106552(17)231112(10)ANFY1675\nANFT0487\nANFT1475\nANFT2597\nANFT3760\nANFU0161\nANFU1106\nANFU2985\nANFU3452\nANFU3901\nANFV0842\nANFV1547\nANFW2016\nANFW3148\nANFX0112\nANFX1798\nANFX2273\nANFY0620\nANFY1675\n\nAVFM09080\n(01)00801741106569(17)230604(10)ANFT0471\n(01)00801741106569(17)230611(10)ANFT1476\n(01)00801741106569(17)230618(10)ANFT2598\n(01)00801741106569(17)230625(10)ANFT3587\n(01)00801741106569(17)230713(10)ANFU1517\n(01)00801741106569(17)230716(10)ANFU2245\n(01)00801741106569(17)230723(10)ANFU2986\n(01)00801741106569(17)230809(10)ANFV0843\n(01)00801741106569(17)230820(10)ANFV1931\n(01)00801741106569(17)230823(10)ANFV2292\n(01)00801741106569(17)230827(10)ANFV2576\n(01)00801741106569(17)230903(10)ANFW0162\nANFT0471\nANFT1476\nANFT2598\nANFT3587\nANFU1517\nANFU2245\nANFU2986\nANFV0843\nANFV1931\nANFV2292\nANFV2576\nANFW0162\n\nAVFM09100\n(01)00801741106576(17)230618(10)ANFT2599\n(01)00801741106576(17)230723(10)ANFU2987\n(01)00801741106576(17)230804(10)ANFV0171\nANFT2599\nANFU2987\nANFV0171\n\nAVFM10040\n(01)00801741106583(17)230625(10)ANFT3620\n(01)00801741106583(17)230723(10)ANFU3107\n(01)00801741106583(17)230806(10)ANFV0343\n(01)00801741106583(17)230827(10)ANFV2606\n(01)00801741106583(17)230903(10)ANFW0163\n(01)00801741106583(17)230910(10)ANFW1461\n(01)00801741106583(17)230924(10)ANFW3149\n(01)00801741106583(17)231008(10)ANFX1458\n(01)00801741106583(17)231022(10)ANFX3164\nANFT3620\nANFU3107\nANFV0343\nANFV2606\nANFW0163\nANFW1461\nANFW3149\nANFX1458\nANFX3164\n\nAVFM10060\n(01)00801741106590(17)230604(10)ANFT0453\n(01)00801741106590(17)230604(10)ANFT0481\n(01)00801741106590(17)230611(10)ANFT1477\n(01)00801741106590(17)230618(10)ANFT2600\n(01)00801741106590(17)230625(10)ANFT3621\n(01)00801741106590(17)230702(10)ANFU0187\n(01)00801741106590(17)230716(10)ANFU2246\n(01)00801741106590(17)230716(10)ANFU2271\n(01)00801741106590(17)230723(10)ANFU2989\n(01)00801741106590(17)230728(10)ANFU3606\n(01)00801741106590(17)230813(10)ANFV1043\n(01)00801741106590(17)230827(10)ANFV2577\n(01)00801741106590(17)230903(10)ANFW0190\n(01)00801741106590(17)230910(10)ANFW1462\n(01)00801741106590(17)230917(10)ANFW2017\n(01)00801741106590(17)230924(10)ANFW3150\n(01)00801741106590(17)231015(10)ANFX2039\n(01)00801741106590(17)231015(10)ANFX2266\n(01)00801741106590(17)231028(10)ANFX3741\n(01)00801741106590(17)231112(10)ANFY1676\nANFT0453\nANFT0481\nANFT1477\nANFT2600\nANFT3621\nANFU0187\nANFU2246\nANFU2271\nANFU2989\nANFU3606\nANFV1043\nANFV2577\nANFW0190\nANFW1462\nANFW2017\nANFW3150\nANFX2039\nANFX2266\nANFX3741\nANFY1676\n\nAVFM10080\n(01)00801741106606(17)230604(10)ANFT0468\n(01)00801741106606(17)230611(10)ANFT1478\n(01)00801741106606(17)230702(10)ANFU0162\n(01)00801741106606(17)230716(10)ANFU2247\n(01)00801741106606(17)230723(10)ANFU2990\n(01)00801741106606(17)230813(10)ANFV1044\n(01)00801741106606(17)230910(10)ANFW1486\n(01)00801741106606(17)230917(10)ANFW2018\n(01)00801741106606(17)230924(10)ANFW3151\n(01)00801741106606(17)231022(10)ANFX3126\n(01)00801741106606(17)231029(10)ANFX4100\n(01)00801741106606(17)231101(10)ANFY0008\nANFT0468\nANFT1478\nANFU0162\nANFU2247\nANFU2990\nANFV1044\nANFW1486\nANFW2018\nANFW3151\nANFX3126\nANFX4100\nANFY0008\n\nAVFM10100\n(01)00801741106613(17)230611(10)ANFT1479\n(01)00801741106613(17)230716(10)ANFU2248\n(01)00801741106613(17)230917(10)ANFW2019\n(01)00801741106613(17)230924(10)ANFW3152\n(01)00801741106613(17)231022(10)ANFX3165\n(01)00801741106613(17)231105(10)ANFY0657\n(01)00801741106613(17)231216(10)ANFZ1833\nANFT1479\nANFU2248\nANFW2019\nANFW3152\nANFX3165\nANFY0657\nANFZ1833\n\nAVSL06040\n(01)00801741106637(17)230611(10)ANFT1489\n(01)00801741106637(17)230924(10)ANFW3154\nANFT1489\nANFW3154\n\nAVSL06060\n(01)00801741106644(17)230903(10)ANFW0192\n(01)00801741106644(17)231105(10)ANFY0662\nANFW0192\nANFY0662\n\nAVSL06080\n(01)00801741106651(17)230625(10)ANFT3590\nANFT3590\t\n\t\nAVSL06100\n(01)00801741106668(17)230806(10)ANFV0344\n(01)00801741106668(17)231105(10)ANFY0663\nANFV0344\nANFY0663\n\nAVSL07040\n(01)00801741106682(17)230604(10)ANFT0475\n(01)00801741106682(17)230917(10)ANFW2174\nANFT0475\nANFW2174\n\nAVSL07060\n(01)00801741106699(17)230611(10)ANFT1490\n(01)00801741106699(17)230730(10)ANFU4194\n(01)00801741106699(17)230806(10)ANFV0316\n(01)00801741106699(17)230917(10)ANFW2021\nANFT1490\nANFU4194\nANFV0316\nANFW2021\n\nAVSL07080\n(01)00801741106705(17)230813(10)ANFV1066\n(01)00801741106705(17)230903(10)ANFW0199\nANFV1066\nANFW0199\n\nAVSL07100\n(01)00801741106712(17)230721(10)ANFU2534\n(01)00801741106712(17)231105(10)ANFY0664\nANFU2534\nANFY0664\n\nAVSL08040\n(01)00801741106736(17)230806(10)ANFV0315\nANFV0315\n\nAVSL08060\n(01)00801741106743(17)230820(10)ANFV1952\n(01)00801741106743(17)230827(10)ANFV2608\n(01)00801741106743(17)230903(10)ANFW0193\n(01)00801741106743(17)230924(10)ANFW3155\nANFV1952\nANFV2608\nANFW0193\nANFW3155\n\nAVSL08080\n(01)00801741106750(17)230625(10)ANFT3591\n(01)00801741106750(17)231022(10)ANFX3167\nANFT3591\nANFX3167\n\nAVSL08100\n(01)00801741106767(17)230924(10)ANFW3156\n(01)00801741106767(17)231112(10)ANFY1680\nANFW3156\nANFY1680\n\nAVSL09040\n(01)00801741106781(17)230924(10)ANFW3157\nANFW3157\n\t\nAVSL09060\n(01)00801741106798(17)230702(10)ANFU0166\n(01)00801741106798(17)230903(10)ANFW0200\nANFU0166\nANFW0200\n\nAVSL09080\n(01)00801741106804(17)231112(10)ANFY1681\nANFY1681\n\nAVSL09100\n(01)00801741106811(17)230709(10)ANFU1080\n(01)00801741106811(17)230924(10)ANFW3159\nANFU1080\nANFW3159\n\nAVSL10040\n(01)00801741106835(17)230806(10)ANFV0324\nANFV0324\n\nAVSL10080\n(01)00801741106859(17)230806(10)ANFV0334\n(01)00801741106859(17)231105(10)ANFY0621\nANFV0334\nANFY0621\n\nAVSL10100\n(01)00801741106866(17)231022(10)ANFX3163\nANFX3163\n\nAVSM06030\n(01)00801741106170(17)230827(10)ANFV2609\n(01)00801741106170(17)230924(10)ANFW3160\nANFV2609\nANFW3160\n\nAVSM06040\n(01)00801741106187(17)230604(10)ANFT0455\n(01)00801741106187(17)230611(10)ANFT1491\n(01)00801741106187(17)230714(10)ANFU1731\n(01)00801741106187(17)230716(10)ANFU2251\n(01)00801741106187(17)230903(10)ANFW0194\n(01)00801741106187(17)230910(10)ANFW1465\n(01)00801741106187(17)230917(10)ANFW2022\n(01)00801741106187(17)230924(10)ANFW3161\n(01)00801741106187(17)231015(10)ANFX2275\n(01)00801741106187(17)231105(10)ANFY0622\nANFT0455\nANFT1491\nANFU1731\nANFU2251\nANFW0194\nANFW1465\nANFW2022\nANFW3161\nANFX2275\nANFY0622\n\nAVSM06060\n(01)00801741106194(17)230604(10)ANFT0493\n(01)00801741106194(17)230709(10)ANFU1076\n(01)00801741106194(17)230806(10)ANFV0345\n(01)00801741106194(17)230903(10)ANFW0195\n(01)00801741106194(17)230910(10)ANFW1466\n(01)00801741106194(17)230917(10)ANFW2023\n(01)00801741106194(17)230924(10)ANFW3162\n(01)00801741106194(17)231001(10)ANFX0091\n(01)00801741106194(17)231015(10)ANFX2276\n(01)00801741106194(17)231029(10)ANFX4104\n(01)00801741106194(17)231105(10)ANFY0666\nANFT0493\nANFU1076\nANFV0345\nANFW0195\nANFW1466\nANFW2023\nANFW3162\nANFX0091\nANFX2276\nANFX4104\nANFY0666\n\nAVSM06080\n(01)00801741106200(17)230827(10)ANFV2610\n(01)00801741106200(17)230903(10)ANFW0196\n(01)00801741106200(17)230924(10)ANFW3163\n(01)00801741106200(17)231015(10)ANFX2277\n(01)00801741106200(17)231105(10)ANFY0623\n(01)00801741106200(17)231112(10)ANFY1682\nANFV2610\nANFW0196\nANFW3163\nANFX2277\nANFY0623\nANFY1682\n\nAVSM06100\n(01)00801741106217(17)230618(10)ANFT2601\n(01)00801741106217(17)230924(10)ANFW3164\nANFT2601\nANFW3164\n\nAVSM07030\n(01)00801741106224(17)230917(10)ANFW2024\n(01)00801741106224(17)230924(10)ANFW3165\n(01)00801741106224(17)231029(10)ANFX4137\nANFW2024\nANFW3165\nANFX4137\n\nAVSM07040\n(01)00801741106231(17)230604(10)ANFT0476\n(01)00801741106231(17)230611(10)ANFT1493\n(01)00801741106231(17)230618(10)ANFT2602\n(01)00801741106231(17)230709(10)ANFU1077\n(01)00801741106231(17)230716(10)ANFU2252\n(01)00801741106231(17)230723(10)ANFU2991\n(01)00801741106231(17)230730(10)ANFU4088\n(01)00801741106231(17)230806(10)ANFV0355\n(01)00801741106231(17)230813(10)ANFV1045\n(01)00801741106231(17)230827(10)ANFV2578\n(01)00801741106231(17)230903(10)ANFW0164\n(01)00801741106231(17)230917(10)ANFW2025\n(01)00801741106231(17)230924(10)ANFW3166\n(01)00801741106231(17)231001(10)ANFX0101\n(01)00801741106231(17)231015(10)ANFX2278\n(01)00801741106231(17)231022(10)ANFX3173\n(01)00801741106231(17)231029(10)ANFX4105\n(01)00801741106231(17)231105(10)ANFY0668\n(01)00801741106231(17)231112(10)ANFY1683\n(01)00801741106231(17)231215(10)ANFZ1828\nANFT0476\nANFT1493\nANFT2602\nANFU1077\nANFU2252\nANFU2991\nANFU4088\nANFV0355\nANFV1045\nANFV2578\nANFW0164\nANFW2025\nANFW3166\nANFX0101\nANFX2278\nANFX3173\nANFX4105\nANFY0668\nANFY1683\nANFZ1828\n\nAVSM07060\n(01)00801741106248(17)230604(10)ANFT0456\n(01)00801741106248(17)230611(10)ANFT1492\n(01)00801741106248(17)230618(10)ANFT2603\n(01)00801741106248(17)230709(10)ANFU1078\n(01)00801741106248(17)230713(10)ANFU1518\n(01)00801741106248(17)230716(10)ANFU2253\n(01)00801741106248(17)230723(10)ANFU2992\n(01)00801741106248(17)230813(10)ANFV1061\n(01)00801741106248(17)230827(10)ANFV2612\n(01)00801741106248(17)230903(10)ANFW0165\n(01)00801741106248(17)230903(10)ANFW0183\n(01)00801741106248(17)230910(10)ANFW1467\n(01)00801741106248(17)230917(10)ANFW2026\n(01)00801741106248(17)230924(10)ANFW3167\n(01)00801741106248(17)231015(10)ANFX2038\n(01)00801741106248(17)231015(10)ANFX2270\n(01)00801741106248(17)231026(10)ANFX3589\n(01)00801741106248(17)231029(10)ANFX4106\n(01)00801741106248(17)231112(10)ANFY1684\nANFT0456\nANFT1492\nANFT2603\nANFU1078\nANFU1518\nANFU2253\nANFU2992\nANFV1061\nANFV2612\nANFW0165\nANFW0183\nANFW1467\nANFW2026\nANFW3167\nANFX2038\nANFX2270\nANFX3589\nANFX4106\nANFY1684\n\nAVSM07080\n(01)00801741106255(17)230604(10)ANFT0457\n(01)00801741106255(17)230618(10)ANFT2604\n(01)00801741106255(17)230714(10)ANFU1729\n(01)00801741106255(17)230716(10)ANFU2275\n(01)00801741106255(17)230723(10)ANFU2993\n(01)00801741106255(17)230903(10)ANFW0166\n(01)00801741106255(17)230910(10)ANFW1468\n(01)00801741106255(17)230924(10)ANFW3168\n(01)00801741106255(17)231001(10)ANFX0113\n(01)00801741106255(17)231015(10)ANFX2229\n(01)00801741106255(17)231029(10)ANFX4139\n(01)00801741106255(17)231105(10)ANFY0624\n(01)00801741106255(17)231112(10)ANFY1685\n(01)00801741106255(17)231112(10)ANFY1832\nANFT0457\nANFT2604\nANFU1729\nANFU2275\nANFU2993\nANFW0166\nANFW1468\nANFW3168\nANFX0113\nANFX2229\nANFX4139\nANFY0624\nANFY1685\nANFY1832\n\nAVSM07100\n(01)00801741106262(17)230604(10)ANFT0458\n(01)00801741106262(17)230618(10)ANFT2605\n(01)00801741106262(17)230713(10)ANFU1516\n(01)00801741106262(17)230716(10)ANFU2255\n(01)00801741106262(17)230727(10)ANFU3322\n(01)00801741106262(17)230823(10)ANFV2293\n(01)00801741106262(17)230827(10)ANFV2579\n(01)00801741106262(17)230917(10)ANFW2027\n(01)00801741106262(17)231007(10)ANFX1079\n(01)00801741106262(17)231028(10)ANFX3739\nANFT0458\nANFT2605\nANFU1516\nANFU2255\nANFU3322\nANFV2293\nANFV2579\nANFW2027\nANFX1079\nANFX3739\n\nAVSM08030\n(01)00801741106279(17)230723(10)ANFU3006\n(01)00801741106279(17)230730(10)ANFU4089\n(01)00801741106279(17)230820(10)ANFV1935\n(01)00801741106279(17)230903(10)ANFW0167\n(01)00801741106279(17)231001(10)ANFX0076\n(01)00801741106279(17)231105(10)ANFY0667\nANFU3006\nANFU4089\nANFV1935\nANFW0167\nANFX0076\nANFY0667\n\nAVSM08040\n(01)00801741106286(17)230604(10)ANFT0459\n(01)00801741106286(17)230618(10)ANFT2616\n(01)00801741106286(17)230618(10)ANFT2626\n(01)00801741106286(17)230705(10)ANFU0489\n(01)00801741106286(17)230723(10)ANFU2994\n(01)00801741106286(17)230730(10)ANFU4090\n(01)00801741106286(17)230806(10)ANFV0325\n(01)00801741106286(17)230813(10)ANFV1052\n(01)00801741106286(17)230813(10)ANFV1062\n(01)00801741106286(17)230813(10)ANFV1068\n(01)00801741106286(17)230820(10)ANFV1936\n(01)00801741106286(17)230827(10)ANFV2580\n(01)00801741106286(17)230903(10)ANFW0168\n(01)00801741106286(17)230910(10)ANFW1469\n(01)00801741106286(17)230917(10)ANFW2028\n(01)00801741106286(17)230924(10)ANFW3158\n(01)00801741106286(17)231001(10)ANFX0077\n(01)00801741106286(17)231001(10)ANFX0107\n(01)00801741106286(17)231008(10)ANFX1419\n(01)00801741106286(17)231015(10)ANFX2230\n(01)00801741106286(17)231022(10)ANFX2965\n(01)00801741106286(17)231022(10)ANFX3174\n(01)00801741106286(17)231105(10)ANFY0614\n(01)00801741106286(17)231105(10)ANFY0625\n(01)00801741106286(17)231112(10)ANFY1671\n(01)00801741106286(17)231112(10)ANFY1686\nANFT0459\nANFT2616\nANFT2626\nANFU0489\nANFU2994\nANFU4090\nANFV0325\nANFV1052\nANFV1062\nANFV1068\nANFV1936\nANFV2580\nANFW0168\nANFW1469\nANFW2028\nANFW3158\nANFX0077\nANFX0107\nANFX1419\nANFX2230\nANFX2965\nANFX3174\nANFY0614\nANFY0625\nANFY1671\nANFY1686\n\nAVSM08060\n(01)00801741106293(17)230528(10)ANFS4997\n(01)00801741106293(17)230604(10)ANFT0477\n(01)00801741106293(17)230611(10)ANFT1488\n(01)00801741106293(17)230611(10)ANFT1528\n(01)00801741106293(17)230618(10)ANFT2606\n(01)00801741106293(17)230618(10)ANFT2634\n(01)00801741106293(17)230709(10)ANFU1104\n(01)00801741106293(17)230716(10)ANFU2254\n(01)00801741106293(17)230716(10)ANFU2265\n(01)00801741106293(17)230723(10)ANFU2995\n(01)00801741106293(17)230730(10)ANFU4091\n(01)00801741106293(17)230806(10)ANFV0317\n(01)00801741106293(17)230806(10)ANFV0326\n(01)00801741106293(17)230806(10)ANFV0335\n(01)00801741106293(17)230806(10)ANFV0346\n(01)00801741106293(17)230806(10)ANFV0356\n(01)00801741106293(17)230813(10)ANFV1063\n(01)00801741106293(17)230813(10)ANFV1073\n(01)00801741106293(17)230820(10)ANFV1930\n(01)00801741106293(17)230820(10)ANFV1942\n(01)00801741106293(17)230820(10)ANFV1951\n(01)00801741106293(17)230827(10)ANFV2581\n(01)00801741106293(17)230827(10)ANFV2597\n(01)00801741106293(17)230827(10)ANFV2611\n(01)00801741106293(17)230903(10)ANFW0169\n(01)00801741106293(17)230903(10)ANFW0191\n(01)00801741106293(17)230910(10)ANFW1470\n(01)00801741106293(17)230910(10)ANFW1488\n(01)00801741106293(17)230917(10)ANFW2058\n(01)00801741106293(17)230924(10)ANFW3169\n(01)00801741106293(17)231001(10)ANFX0084\n(01)00801741106293(17)231001(10)ANFX0085\n(01)00801741106293(17)231001(10)ANFX0092\n(01)00801741106293(17)231008(10)ANFX1420\n(01)00801741106293(17)231008(10)ANFX1439\n(01)00801741106293(17)231015(10)ANFX2231\n(01)00801741106293(17)231015(10)ANFX2258\n(01)00801741106293(17)231022(10)ANFX3129\n(01)00801741106293(17)231022(10)ANFX3162\n(01)00801741106293(17)231105(10)ANFY0626\n(01)00801741106293(17)231105(10)ANFY0640\n(01)00801741106293(17)231105(10)ANFY0659\n(01)00801741106293(17)231112(10)ANFY1687\n(01)00801741106293(17)231112(10)ANFY1718\n(01)00801741106293(17)231116(10)ANFY2290\n(01)00801741106293(17)231118(10)ANFY2512\nANFS4997\nANFT0477\nANFT1488\nANFT1528\nANFT2606\nANFT2634\nANFU1104\nANFU2254\nANFU2265\nANFU2995\nANFU4091\nANFV0317\nANFV0326\nANFV0335\nANFV0346\nANFV0356\nANFV1063\nANFV1073\nANFV1930\nANFV1942\nANFV1951\nANFV2581\nANFV2597\nANFV2611\nANFW0169\nANFW0191\nANFW1470\nANFW1488\nANFW2058\nANFW3169\nANFX0084\nANFX0085\nANFX0092\nANFX1420\nANFX1439\nANFX2231\nANFX2258\nANFX3129\nANFX3162\nANFY0626\nANFY0640\nANFY0659\nANFY1687\nANFY1718\nANFY2290\nANFY2512\n\nAVSM08080\n(01)00801741106309(17)230604(10)ANFT0460\n(01)00801741106309(17)230604(10)ANFT0473\n(01)00801741106309(17)230611(10)ANFT1494\n(01)00801741106309(17)230618(10)ANFT2607\n(01)00801741106309(17)230702(10)ANFU0167\n(01)00801741106309(17)230709(10)ANFU1079\n(01)00801741106309(17)230730(10)ANFU4092\n(01)00801741106309(17)230813(10)ANFV1046\n(01)00801741106309(17)230813(10)ANFV1069\n(01)00801741106309(17)230813(10)ANFV1074\n(01)00801741106309(17)230820(10)ANFV1937\n(01)00801741106309(17)230820(10)ANFV1943\n(01)00801741106309(17)230827(10)ANFV2582\n(01)00801741106309(17)230903(10)ANFW0171\n(01)00801741106309(17)230910(10)ANFW1471\n(01)00801741106309(17)230910(10)ANFW1491\n(01)00801741106309(17)230917(10)ANFW2029\n(01)00801741106309(17)230924(10)ANFW3170\n(01)00801741106309(17)231001(10)ANFX0093\n(01)00801741106309(17)231001(10)ANFX0102\n(01)00801741106309(17)231008(10)ANFX1454\n(01)00801741106309(17)231015(10)ANFX2232\n(01)00801741106309(17)231022(10)ANFX2966\n(01)00801741106309(17)231022(10)ANFX3175\n(01)00801741106309(17)231029(10)ANFX4107\n(01)00801741106309(17)231029(10)ANFX4136\n(01)00801741106309(17)231101(10)ANFY0001\n(01)00801741106309(17)231105(10)ANFY0669\nANFT0460\nANFT0473\nANFT1494\nANFT2607\nANFU0167\nANFU1079\nANFU4092\nANFV1046\nANFV1069\nANFV1074\nANFV1937\nANFV1943\nANFV2582\nANFW0171\nANFW1471\nANFW1491\nANFW2029\nANFW3170\nANFX0093\nANFX0102\nANFX1454\nANFX2232\nANFX2966\nANFX3175\nANFX4107\nANFX4136\nANFY0001\nANFY0669\n\nAVSM08100\n(01)00801741106316(17)230604(10)ANFT0461\n(01)00801741106316(17)230611(10)ANFT1495\n(01)00801741106316(17)230618(10)ANFT2608\n(01)00801741106316(17)230709(10)ANFU1081\n(01)00801741106316(17)230714(10)ANFU1730\n(01)00801741106316(17)230716(10)ANFU2256\n(01)00801741106316(17)230723(10)ANFU2996\n(01)00801741106316(17)230813(10)ANFV1075\n(01)00801741106316(17)230827(10)ANFV2583\n(01)00801741106316(17)230903(10)ANFW0201\n(01)00801741106316(17)230910(10)ANFW1472\n(01)00801741106316(17)230917(10)ANFW2052\n(01)00801741106316(17)230924(10)ANFW3171\n(01)00801741106316(17)231001(10)ANFX0078\n(01)00801741106316(17)231008(10)ANFX1421\n(01)00801741106316(17)231015(10)ANFX2233\n(01)00801741106316(17)231022(10)ANFX3130\n(01)00801741106316(17)231029(10)ANFX4108\n(01)00801741106316(17)231029(10)ANFX4117\n(01)00801741106316(17)231112(10)ANFY1688\nANFT0461\nANFT1495\nANFT2608\nANFU1081\nANFU1730\nANFU2256\nANFU2996\nANFV1075\nANFV2583\nANFW0201\nANFW1472\nANFW2052\nANFW3171\nANFX0078\nANFX1421\nANFX2233\nANFX3130\nANFX4108\nANFX4117\nANFY1688\n\nAVSM09030\n(01)00801741106323(17)231112(10)ANFY1689\nANFY1689\t\n\nAVSM09040\n(01)00801741106330(17)230604(10)ANFT0462\n(01)00801741106330(17)230611(10)ANFT1496\n(01)00801741106330(17)230702(10)ANFU0168\n(01)00801741106330(17)230709(10)ANFU1082\n(01)00801741106330(17)230728(10)ANFU3607\n(01)00801741106330(17)230730(10)ANFU4093\n(01)00801741106330(17)230813(10)ANFV1076\n(01)00801741106330(17)230820(10)ANFV1938\n(01)00801741106330(17)230827(10)ANFV2584\n(01)00801741106330(17)230903(10)ANFW0172\n(01)00801741106330(17)230910(10)ANFW1473\n(01)00801741106330(17)230917(10)ANFW2053\n(01)00801741106330(17)230924(10)ANFW3172\n(01)00801741106330(17)231001(10)ANFX0103\n(01)00801741106330(17)231015(10)ANFX2234\n(01)00801741106330(17)231022(10)ANFX2967\n(01)00801741106330(17)231022(10)ANFX3131\nANFT0462\nANFT1496\nANFU0168\nANFU1082\nANFU3607\nANFU4093\nANFV1076\nANFV1938\nANFV2584\nANFW0172\nANFW1473\nANFW2053\nANFW3172\nANFX0103\nANFX2234\nANFX2967\nANFX3131\n\nAVSM09060\n(01)00801741106347(17)230528(10)ANFS5012\n(01)00801741106347(17)230604(10)ANFT0479\n(01)00801741106347(17)230611(10)ANFT1497\n(01)00801741106347(17)230618(10)ANFT2609\n(01)00801741106347(17)230709(10)ANFU1083\n(01)00801741106347(17)230716(10)ANFU2257\n(01)00801741106347(17)230723(10)ANFU2997\n(01)00801741106347(17)230728(10)ANFU3608\n(01)00801741106347(17)230730(10)ANFU4094\n(01)00801741106347(17)230813(10)ANFV1053\n(01)00801741106347(17)230820(10)ANFV1939\n(01)00801741106347(17)230827(10)ANFV2585\n(01)00801741106347(17)230903(10)ANFW0173\n(01)00801741106347(17)230903(10)ANFW0188\n(01)00801741106347(17)230917(10)ANFW2054\n(01)00801741106347(17)230924(10)ANFW3173\n(01)00801741106347(17)231001(10)ANFX0108\n(01)00801741106347(17)231001(10)ANFX0114\n(01)00801741106347(17)231008(10)ANFX1422\n(01)00801741106347(17)231015(10)ANFX2236\n(01)00801741106347(17)231022(10)ANFX3132\n(01)00801741106347(17)231022(10)ANFX3144\n(01)00801741106347(17)231105(10)ANFY0627\n(01)00801741106347(17)231112(10)ANFY1690\n(01)00801741106347(17)231112(10)ANFY1702\n(01)00801741106347(17)231119(10)ANFY2817\nANFS5012\nANFT0479\nANFT1497\nANFT2609\nANFU1083\nANFU2257\nANFU2997\nANFU3608\nANFU4094\nANFV1053\nANFV1939\nANFV2585\nANFW0173\nANFW0188\nANFW2054\nANFW3173\nANFX0108\nANFX0114\nANFX1422\nANFX2236\nANFX3132\nANFX3144\nANFY0627\nANFY1690\nANFY1702\nANFY2817\n\nAVSM09080\n(01)00801741106354(17)230528(10)ANFS5007\n(01)00801741106354(17)230604(10)ANFT0463\n(01)00801741106354(17)230611(10)ANFT1498\n(01)00801741106354(17)230618(10)ANFT2610\n(01)00801741106354(17)230625(10)ANFT3624\n(01)00801741106354(17)230702(10)ANFU0169\n(01)00801741106354(17)230709(10)ANFU1084\n(01)00801741106354(17)230716(10)ANFU2258\n(01)00801741106354(17)230723(10)ANFU2998\n(01)00801741106354(17)230813(10)ANFV1047\n(01)00801741106354(17)230820(10)ANFV1940\n(01)00801741106354(17)230827(10)ANFV2586\n(01)00801741106354(17)230903(10)ANFW0174\n(01)00801741106354(17)230917(10)ANFW2055\n(01)00801741106354(17)230924(10)ANFW3174\n(01)00801741106354(17)231001(10)ANFX0094\n(01)00801741106354(17)231008(10)ANFX1423\n(01)00801741106354(17)231015(10)ANFX2237\n(01)00801741106354(17)231022(10)ANFX3133\n(01)00801741106354(17)231022(10)ANFX3153\n(01)00801741106354(17)231105(10)ANFY0628\n(01)00801741106354(17)231112(10)ANFY1691\n(01)00801741106354(17)231119(10)ANFY2818\nANFS5007\nANFT0463\nANFT1498\nANFT2610\nANFT3624\nANFU0169\nANFU1084\nANFU2258\nANFU2998\nANFV1047\nANFV1940\nANFV2586\nANFW0174\nANFW2055\nANFW3174\nANFX0094\nANFX1423\nANFX2237\nANFX3133\nANFX3153\nANFY0628\nANFY1691\nANFY2818\n\nAVSM09100\n(01)00801741106361(17)230528(10)ANFS5008\n(01)00801741106361(17)230604(10)ANFT0464\n(01)00801741106361(17)230611(10)ANFT1527\n(01)00801741106361(17)230618(10)ANFT2611\n(01)00801741106361(17)230625(10)ANFT3593\n(01)00801741106361(17)230723(10)ANFU2999\n(01)00801741106361(17)230820(10)ANFV1941\n(01)00801741106361(17)230827(10)ANFV2587\n(01)00801741106361(17)230903(10)ANFW0175\n(01)00801741106361(17)230910(10)ANFW1474\n(01)00801741106361(17)230917(10)ANFW2056\n(01)00801741106361(17)231008(10)ANFX1424\n(01)00801741106361(17)231015(10)ANFX2239\n(01)00801741106361(17)231022(10)ANFX3134\n(01)00801741106361(17)231105(10)ANFY0629\nANFS5008\nANFT0464\nANFT1527\nANFT2611\nANFT3593\nANFU2999\nANFV1941\nANFV2587\nANFW0175\nANFW1474\nANFW2056\nANFX1424\nANFX2239\nANFX3134\nANFY0629\n\nAVSM10030\n(01)00801741106378(17)231001(10)ANFX0086\nANFX0086\n\nAVSM10040\n(01)00801741106385(17)230528(10)ANFS5002\n(01)00801741106385(17)230604(10)ANFT0465\n(01)00801741106385(17)230618(10)ANFT2612\n(01)00801741106385(17)230702(10)ANFU0170\n(01)00801741106385(17)230709(10)ANFU1085\n(01)00801741106385(17)230716(10)ANFU2259\n(01)00801741106385(17)230723(10)ANFU2988\n(01)00801741106385(17)230730(10)ANFU4095\n(01)00801741106385(17)230820(10)ANFV1933\n(01)00801741106385(17)230820(10)ANFV1946\n(01)00801741106385(17)230827(10)ANFV2588\n(01)00801741106385(17)230903(10)ANFW0176\n(01)00801741106385(17)230910(10)ANFW1475\n(01)00801741106385(17)230917(10)ANFW2057\n(01)00801741106385(17)231001(10)ANFX0079\n(01)00801741106385(17)231001(10)ANFX0087\n(01)00801741106385(17)231008(10)ANFX1425\n(01)00801741106385(17)231015(10)ANFX2241\n(01)00801741106385(17)231022(10)ANFX3135\n(01)00801741106385(17)231022(10)ANFX3171\n(01)00801741106385(17)231029(10)ANFX4140\n(01)00801741106385(17)231105(10)ANFY0630\n(01)00801741106385(17)231105(10)ANFY0643\n(01)00801741106385(17)231112(10)ANFY1693\n(01)00801741106385(17)231119(10)ANFY2820\nANFS5002\nANFT0465\nANFT2612\nANFU0170\nANFU1085\nANFU2259\nANFU2988\nANFU4095\nANFV1933\nANFV1946\nANFV2588\nANFW0176\nANFW1475\nANFW2057\nANFX0079\nANFX0087\nANFX1425\nANFX2241\nANFX3135\nANFX3171\nANFX4140\nANFY0630\nANFY0643\nANFY1693\nANFY2820\n\nAVSM10060\n(01)00801741106392(17)230604(10)ANFT0478\n(01)00801741106392(17)230611(10)ANFT1511\n(01)00801741106392(17)230618(10)ANFT2613\n(01)00801741106392(17)230702(10)ANFU0171\n(01)00801741106392(17)230709(10)ANFU1086\n(01)00801741106392(17)230716(10)ANFU2260\n(01)00801741106392(17)230723(10)ANFU3000\n(01)00801741106392(17)230723(10)ANFU3011\n(01)00801741106392(17)230730(10)ANFU4096\n(01)00801741106392(17)230820(10)ANFV1944\n(01)00801741106392(17)230827(10)ANFV2589\n(01)00801741106392(17)230827(10)ANFV2602\n(01)00801741106392(17)230903(10)ANFW0177\n(01)00801741106392(17)230910(10)ANFW1460\n(01)00801741106392(17)230910(10)ANFW1476\n(01)00801741106392(17)230910(10)ANFW1502\n(01)00801741106392(17)230917(10)ANFW2051\n(01)00801741106392(17)231001(10)ANFX0080\n(01)00801741106392(17)231001(10)ANFX0088\n(01)00801741106392(17)231001(10)ANFX0095\n(01)00801741106392(17)231001(10)ANFX0104\n(01)00801741106392(17)231008(10)ANFX1426\n(01)00801741106392(17)231008(10)ANFX1451\n(01)00801741106392(17)231015(10)ANFX2243\n(01)00801741106392(17)231022(10)ANFX3136\n(01)00801741106392(17)231029(10)ANFX4102\n(01)00801741106392(17)231029(10)ANFX4109\n(01)00801741106392(17)231029(10)ANFX4130\n(01)00801741106392(17)231112(10)ANFY1694\n(01)00801741106392(17)231118(10)ANFY2513\n(01)00801741106392(17)231119(10)ANFY2857\nANFT0478\nANFT1511\nANFT2613\nANFU0171\nANFU1086\nANFU2260\nANFU3000\nANFU3011\nANFU4096\nANFV1944\nANFV2589\nANFV2602\nANFW0177\nANFW1460\nANFW1476\nANFW1502\nANFW2051\nANFX0080\nANFX0088\nANFX0095\nANFX0104\nANFX1426\nANFX1451\nANFX2243\nANFX3136\nANFX4102\nANFX4109\nANFX4130\nANFY1694\nANFY2513\nANFY2857\n\nAVSM10080\n(01)00801741106408(17)230604(10)ANFT0466\n(01)00801741106408(17)230611(10)ANFT1499\n(01)00801741106408(17)230618(10)ANFT2647\n(01)00801741106408(17)230709(10)ANFU1087\n(01)00801741106408(17)230716(10)ANFU2261\n(01)00801741106408(17)230723(10)ANFU3001\n(01)00801741106408(17)230727(10)ANFU3324\n(01)00801741106408(17)230806(10)ANFV0336\n(01)00801741106408(17)230827(10)ANFV2613\n(01)00801741106408(17)230903(10)ANFW0197\n(01)00801741106408(17)230910(10)ANFW1477\n(01)00801741106408(17)230910(10)ANFW1498\n(01)00801741106408(17)230917(10)ANFW2059\n(01)00801741106408(17)231001(10)ANFX0096\n(01)00801741106408(17)231008(10)ANFX1427\n(01)00801741106408(17)231015(10)ANFX2244\n(01)00801741106408(17)231029(10)ANFX4111\n(01)00801741106408(17)231029(10)ANFX4122\n(01)00801741106408(17)231105(10)ANFY0631\n(01)00801741106408(17)231112(10)ANFY1695\nANFT0466\nANFT1499\nANFT2647\nANFU1087\nANFU2261\nANFU3001\nANFU3324\nANFV0336\nANFV2613\nANFW0197\nANFW1477\nANFW1498\nANFW2059\nANFX0096\nANFX1427\nANFX2244\nANFX4111\nANFX4122\nANFY0631\nANFY1695\n\nAVSM10100\n(01)00801741106415(17)230604(10)ANFT0490\n(01)00801741106415(17)230611(10)ANFT1500\n(01)00801741106415(17)230618(10)ANFT2614\n(01)00801741106415(17)230702(10)ANFU0172\n(01)00801741106415(17)230716(10)ANFU2262\n(01)00801741106415(17)230723(10)ANFU3002\n(01)00801741106415(17)230827(10)ANFV2614\n(01)00801741106415(17)230903(10)ANFW0198\n(01)00801741106415(17)230910(10)ANFW1478\n(01)00801741106415(17)231001(10)ANFX0105\n(01)00801741106415(17)231008(10)ANFX1428\n(01)00801741106415(17)231015(10)ANFX2245\n(01)00801741106415(17)231029(10)ANFX4110\n(01)00801741106415(17)231105(10)ANFY0632\n(01)00801741106415(17)231112(10)ANFY1696\nANFT0490\nANFT1500\nANFT2614\nANFU0172\nANFU2262\nANFU3002\nANFV2614\nANFW0198\nANFW1478\nANFX0105\nANFX1428\nANFX2245\nANFX4110\nANFY0632\nANFY1696",
      "firm_fei_number": "2020394",
      "recalling_firm": "Bard Peripheral Vascular Inc",
      "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St",
      "address_2": "Bldg 1",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85281-2438",
      "additional_info_contact": "Padraic OBrien \n480-597-8203",
      "reason_for_recall": "An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.",
      "root_cause_description": "Unknown/Undetermined by firm",
      "action": "On 12/22/2022, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via FedEx and/or email to customers informing them that BD has identified through customer complaints that the Covera\" Vascular Covered Stent has the potential to exhibit deployment issues (i.e., failure to deploy the covered stent) due to slide block bond failures in the device handle.\n\nCustomers are instructed to:\n1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process.\n2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action.\n3. If customers purchased this product from a distributor, contact the distributor for further instructions and replacement, as available, resolution.\n4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not customers have any of the product so that BD may acknowledge receipt of this notification and subsequently process replacements, as available, regarding impacted product.\n5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of.\n6. Please contact BD representative if assistance is required with this process or contact the\nnumber below for further assistance:\nNorth American Regional Complaint Center\nPhone: 1-844-8BD- LIFE (1-844-823-5433)\nSay  Recall  when prompted\nM-F 8am - 5pm CT\nEmail: productcomplaints@bd.com",
      "product_quantity": "10,815 devices (U.S. total)",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, WA, WI, and WV the country of Canada.",
      "openfda": {
        "pma_number": [
          "P130006",
          "P170042",
          "P130029",
          "P060002",
          "P240023"
        ],
        "registration_number": [
          "3033589330",
          "3002807090",
          "3012536737",
          "9681442",
          "3015225571",
          "2020394",
          "1721676",
          "2017233",
          "3002504068",
          "3005941719",
          "3006950086",
          "1721504",
          "1721686",
          "3015309643",
          "1724474",
          "2011171"
        ],
        "fei_number": [
          "3003094851",
          "3033589330",
          "3012536737",
          "3002806368",
          "3015225571",
          "2020394",
          "1721676",
          "3006003617",
          "3002504068",
          "2017233",
          "3006950086",
          "1721504",
          "1721686",
          "3015309643",
          "3002807111",
          "2011171"
        ],
        "device_name": "System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}