{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "150185",
      "product_res_number": "Z-0669-2017",
      "event_date_initiated": "2016-08-04",
      "event_date_created": "2016-11-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-10-19",
      "res_event_number": "75370",
      "product_code": "NIP",
      "pma_numbers": [
        "P140002"
      ],
      "product_description": "MISAGO RX Self Expanding Peripheral Stem",
      "code_info": "150401\t150429\t150713\t150821\t150923\t151009\t160314\t\t 150413\t150501\t150708\t150824\t150915\t151013\t151111\t\t 150415\t150515\t150701\t150716\t150902\t151005\t151106\t\t 150407\t150514\t150707\t150827\t151008\t151109\t160509\t\t 150406\t150501\t150713\t150716\t150825\t151001\t151102\t160315\t160509 150410\t150710\t150831\t150909\t151007\t151012\t151014\t151103\t151208 150417\t150429\t150717\t150910\t151002\t151102\t160510\t\t 150408\t150429\t150701\t150717\t150831\t151013\t151103\t160512\t 150409\t150430\t150518\t150703\t150706\t150903\t150914\t151005\t 150331\t150430\t150708\t150714\t150904\t150910\t151001\t151102\t 150414\t150429\t150715\t150903\t151005\t151029\t160323\t\t 150416\t150518\t150715\t150908\t150915\t151002\t151106\t160328\t 150401\t150430\t150716\t150828\t151006\t\t\t\t 150403\t150514\t150717\t150901\t150909\t151012\t\t\t 150408\t150430\t150713\t150907\t151001\t\t\t\t 150402\t150512\t150713\t150907\t151001",
      "firm_fei_number": "2243441",
      "recalling_firm": "Terumo Medical Corp",
      "address_1": "2101 Cottontail Ln",
      "city": "Somerset",
      "state": "NJ",
      "postal_code": "08873-1277",
      "additional_info_contact": "800-283-7866",
      "reason_for_recall": "During recent routine testing, the MISAGO Peripheral Stent was found not to conform to product specification related to stent diameter at the proximal/distal ends and/or the shape of the stent.",
      "root_cause_description": "Device Design",
      "action": "Terumo Medical Corporation issued an Urgent Product Recall Bulletin dated August 4, 2016, via Fed Ex.\n\nCustomers must immediately discontinue use and quarantine any available stock of the Misago peripheral stent to prevent further use. \n\nThe customers should complete the enclosed Inventory Confirmation form as soon as possible and email or fax the completed form\nto misago.rc@terumomedical.com or (734) 330-2034, Attn: MISAGO Recall.\n\nCustomers are  encourage you to contact Terumo Medical Corporation with any questions or concerns\n-Terumo Medical Corporation Quality Department: 1.800.283.7866, Press 4 for list of departments, Press 7 for Quality Assurance; Monday  Friday, 8 a.m.  5 p.m. ET\n- Email Quality Assurance: misago.rc@terumomedical.com\n- Customer Care: 1.800.888.3786\n- Contact your local Terumo representative",
      "product_quantity": "7,965 units",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "pma_number": [
          "P180003",
          "P140028",
          "P160004",
          "P000033",
          "P040037",
          "P070014",
          "P160025",
          "P110023",
          "P120020",
          "P120002",
          "P050017",
          "P140002",
          "P110040"
        ],
        "registration_number": [
          "1016427",
          "1721686",
          "9681260",
          "3008328690",
          "9616099",
          "1000121056",
          "3009526575",
          "3004091615",
          "9681834",
          "2939561",
          "2024168",
          "3002807090",
          "3014656749",
          "3002504068",
          "3006946276",
          "1048735",
          "8043892",
          "1721676",
          "9681442",
          "2183744",
          "3010273872",
          "2020394",
          "3010155661",
          "2134265",
          "3002807314",
          "3010220595",
          "3011632150",
          "3001845648",
          "1225687",
          "3005941719",
          "3010432890",
          "2011171",
          "3011574793",
          "2183870",
          "1643817",
          "3005580113",
          "8010026",
          "2017233",
          "2124215"
        ],
        "fei_number": [
          "1016427",
          "3002808050",
          "2828",
          "1721686",
          "3008328690",
          "1000121056",
          "3009526575",
          "3006003617",
          "3003528016",
          "3004091615",
          "3002095335",
          "2024168",
          "3014656749",
          "3006946276",
          "3002504068",
          "1048735",
          "3002808327",
          "1721676",
          "2183744",
          "3010273872",
          "2020394",
          "3010155661",
          "3001451463",
          "3002807111",
          "3002807314",
          "3010220595",
          "3002806565",
          "3011632150",
          "3001845648",
          "3002806368",
          "3010432890",
          "2011171",
          "3011574793",
          "2183870",
          "1643817",
          "3005580113",
          "3004635528",
          "2017233",
          "2124215"
        ],
        "device_name": "Stent, Superficial Femoral Artery",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
      }
    }
  ]
}