{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214951", "product_res_number": "Z-2273-2025", "event_date_initiated": "2025-07-07", "event_date_posted": "2025-08-08", "recall_status": "Open, Classified", "res_event_number": "97243", "product_code": "NIM", "pma_numbers": [ "P050019" ], "product_description": "Carotid WALLSTENT Monorail Endoprosthesis Closed Cell Self-Expanding Stent, stent and stent delivery system.\r\n\r\nMaterial numbers:\r\n\r\nH7493915010240\r\nCAROTID WALLSTENT MONORAIL 10.0-24;\r\nH7493915010310\r\nCAROTID WALLSTENT MONORAIL 10.0-31;\r\nH749391506220\r\nCAROTID WALLSTENT MONORAIL 6.0-22;\r\nH749391508210\r\nCAROTID WALLSTENT MONORAIL 8.0-21;\r\nH749391508290\r\nCAROTID WALLSTENT MONORAIL 8.0-29;\r\nH965SCH647010\r\nCAROTID WALLSTENT MONORAIL 6.0-22;\r\nH965SCH647070\r\nCAROTID WALLSTENT MONORAIL 8.0-21;\r\nH965SCH647080\r\nCAROTID WALLSTENT MONORAIL 8.0-29;\r\nH965SCH647090\r\nCAROTID WALLSTENT MONORAIL 8.0-36;\r\nH965SCH647120\r\nCAROTID WALLSTENT MONORAIL 10.0-24;\r\nH965SCH647130\r\nCAROTID WALLSTENT MONORAIL 10.0-31;\r\nH965SCH647140\r\nCAROTID WALLSTENT MONORAIL 10.0-37;\r\nM001719000\r\nCAROTID WALLSTENT MR 6X22 5F 135CM;\r\nM001719010\r\nCAROTID WALLSTENT MR 8X21 5F 135CM;\r\nM001719020\r\nCAROTID WALLSTENT MR 8X29 5F 135CM;\r\nM001719030\r\nCAROTID WALLSTENT MR 8X36 5F 135CM;\r\nM001719040\r\nCAROTID WALLSTENT MR 10X24 5.9F 135CM;\r\nM001719050\r\nCAROTID WALLSTENT MR 10X31 5.9F 135CM;\r\nM001719060\r\nCAROTID WALLSTENT MR 10X37 5.9F 135CM;", "code_info": "1. H7493915010240\nUDI-DI 08714729781097\nBatches\n35277608\n35315983\n35315984\n35315985\n35380314\n35452835\n35452836\n35514614\n35551688\n35551689\n35664523\n35664524\n35750157\n35750158\n35750159\n35750400\n35879409\n35879410\n35921915\n35922951\n35926817\n35926818\n35942366\n36056965\n36058841\n36058842\n36058843\n36096638\n36121883\n36138618\n36138619\n36138801\n36138802\n36138803\n36159671\n36195057\n36195058\n36195059\n36195360\n36205167\n36209423\n36214805\n36214806\n36256192\n36322725\n36348207\n36348208\n36348209\n36498256\n36588496\n36607566\n36711321;\n\n2. H7493915010310\nUDI-DI 08714729781110\nBatches \n35294379\n35294540\n35295922\n35330503\n35330504\n35336132\n35347263\n35382292\n35383351\n35383352\n35453002\n35461487\n35461488\n35528579\n35529200\n35628964\n35628965\n35628966\n35641995\n35662047\n35664484\n35664485\n35750401\n35750402\n35750403\n35750404\n35750405\n35750406\n35750407\n35890012\n35893584\n35893585\n35894358\n35894359\n35938922\n35938923\n35938924\n35938925\n35938926\n36002641\n36002642\n36063291\n36063292\n36105446\n36133161\n36134808\n36144148\n36148535\n36154091\n36154092\n36154093\n36154094\n36154095\n36169871\n36169872\n36197809\n36197810\n36197811\n36197812\n36197813\n36200118\n36202762\n36204350\n36212466\n36212467\n36212468\n36256193\n36256194\n36256195\n36357711\n36357712\n36368143\n36368144\n36368145\n36516036\n36603362\n36603363\n36642784\n36683543\n36688775\n36811476\n36811477\n36818953;\n\n3. H749391506220\nUDI-DI 08714729781158\nBatches\n35582211\n35750408\n35947814\n35947815\n35950476\n36009906\n36292862\n36397124\n36652844;\n\n4. H749391508210\nUDI-DI 08714729781172\nBatches\n35343574\n35438658\n35487375\n35567637\n35652700\n35656388\n35750409\n35757024\n35873346\n35873347\n35901381\n35901382\n35999854\n35999855\n35999856\n36246587\n36246588\n36246589\n36292863\n36306518\n36376412\n36410418\n36410419\n36412851\n36479267\n36565560\n36636529\n36724350\n36777341\n\n5. H749391508290\nUDI-DI 08714729781196\nBatches\n35339488\n35375416\n35375417\n35462381\n35529285\n35529286\n35617101\n35617102\n35618276\n35662042\n35662043\n35749222\n35750156\n35750410\n35750411\n35750412\n35750413\n35771618\n35944023\n35944024\n35946987\n35946988\n35950477\n35950478\n35950479\n35951080\n35951081\n35951082\n35951083\n35961400\n35978120\n36320917\n36320918\n36320919\n36321560\n36322143\n36458848\n36458849\n36458850\n36458851\n36458852\n36465397\n36465398\n36465399\n36505552\n36505553\n36607622\n36683540\n36792075;\n\n6. H965SCH647010\nUDI-DI 08714729263869\nBatches\n35347272\n35347273\n35347274\n35432322\n35432323\n35432324\n35432325\n35435587\n35496538\n35496539\n35510448\n35510449\n35549114\n35558691\n35558692\n35623470\n35623471\n35623472\n35641992\n35757022\n35891995\n35891996\n35903878\n35903879\n35904080\n35904081\n35911104\n35911106\n35926007\n35926017\n35990353\n35990354\n36009907\n36012786\n36012787\n36012788\n36012789\n36222681\n36222683\n36241106\n36241107\n36241108\n36292865\n36292866\n36292867\n36292868\n36292869\n36292870\n36297506\n36297507\n36348203\n36348204\n36357034\n36357035\n36357037\n36402896\n36402897\n36469383\n36469384\n36469385\n36493671\n36515107\n36609942\n36609943\n36609944\n36717345\n36722322\n36769772\n36769773\n36787067;\n\n7. 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H965SCH647080\nUDI-DI 08714729263883\nBatches\n35243220\n35244199\n35244520\n35244521\n35247274\n35247275\n35247276\n35247277\n35247278\n35247279\n35247540\n35247541\n35248292\n35248293\n35248294\n35252806\n35252808\n35252809\n35302655\n35302656\n35302657\n35302658\n35304581\n35305305\n35305306\n35307512\n35307513\n35307514\n35339484\n35339485\n35339486\n35339487\n35357498\n35357499\n35357740\n35361258\n35361259\n35361460\n35361461\n35361462\n35361463\n35362807\n35362808\n35365037\n35365038\n35365039\n35365800\n35365801\n35365802\n35365803\n35365804\n35365805\n35367555\n35370836\n35370837\n35370838\n35370839\n35371180\n35371181\n35371182\n35371183\n35375418\n35375419\n35388606\n35388607\n35388608\n35388609\n35388610\n35388611\n35391026\n35391027\n35391028\n35391029\n35391030\n35393507\n35393508\n35393509\n35393510\n35393511\n35393512\n35394158\n35394159\n35395620\n35395621\n35395622\n35395623\n35395624\n35395625\n35395626\n35395627\n35397442\n35397443\n35397444\n35397445\n35402251\n35402254\n35402257\n35402280\n35402283\n35402284\n35406000\n35406001\n35448176\n35448177\n35450110\n35450111\n35450112\n35450113\n35456213\n35456215\n35456216\n35456217\n35457525\n35457526\n35458769\n35461739\n35461741\n35461742\n35462380\n35462382\n35462383\n35465421\n35465422\n35465423\n35465424\n35468042\n35468043\n35468044\n35468045\n35468046\n35468047\n35468048\n35468049\n35468050\n35468051\n35471389\n35471390\n35471391\n35471392\n35471393\n35476347\n35476348\n35514612\n35518815\n35519420\n35520154\n35520155\n35520156\n35522424\n35522425\n35522699\n35522780\n35522781\n35522782\n35522977\n35522978\n35522979\n35523220\n35523221\n35523222\n35525808\n35525809\n35525810\n35525811\n35526986\n35526987\n35526988\n35528577\n35528578\n35529284\n35529287\n35529629\n35529630\n35529631\n35529632\n35531670\n35531671\n35531672\n35541480\n35541481\n35541482\n35541483\n35542643\n35562259\n35562520\n35565634\n35565635\n35565636\n35585834\n35585835\n35585836\n35585838\n35589525\n35589526\n35590013\n35590014\n35611923\n35611924\n35612128\n35612129\n35612130\n35612131\n35612132\n35612143\n35612144\n35613461\n35613462\n35613463\n35613464\n35613465\n35616796\n35616797\n35616798\n35616799\n35617100\n35618178\n35618179\n35618277\n35620886\n35622733\n35622738\n35622760\n35622761\n35636552\n35636553\n35652778\n35652779\n35653341\n35653342\n35653343\n35655507\n35655508\n35655510\n35655513\n35655514\n35656381\n35656383\n35656384\n35656386\n35656387\n35662005\n35662006\n35662040\n35662041\n35662044\n35662045\n35662046\n35749223\n35755824\n35774932\n35781375\n35781376\n35781377\n35781378\n35781379\n35781880\n35866470\n35866471\n35867497\n35868573\n35868574\n35870253\n35871472\n35871476\n35872080\n35872081\n35873025\n35873026\n35876804\n35876805\n35879407\n35879408\n35881807\n35881808\n35887451\n35887452\n35887453\n35887454\n35891991\n35891992\n35891993\n35891994\n35896872\n35896873\n35899097\n35903147\n35903148\n35903149\n35903150\n35912756\n35912757\n35925347\n35926819\n35928104\n35928105\n35929567\n35929568\n35932458\n35932459\n35979594\n35979595\n35983716\n35988028\n35988445\n35988447\n35989162\n35989177\n35989178\n35989279\n35989720\n35989945\n35989946\n35994087\n35994089\n35994090\n35994091\n35995228\n35995229\n35995230\n35995231\n35997085\n35997978\n35997979\n35998240\n35998241\n35998242\n36006192\n36006193\n36006194\n36006195\n36006196\n36006197\n36006198\n36012790\n36012791\n36012792\n36012793\n36018044\n36018045\n36018046\n36018047\n36026734\n36026735\n36026736\n36026737\n36026738\n36026739\n36026960\n36026961\n36026963\n36026964\n36032712\n36032715\n36032717\n36032719\n36032981\n36036491\n36036492\n36036493\n36036494\n36036495\n36036496\n36038161\n36038162\n36038163\n36040721\n36040722\n36040723\n36040724\n36040725\n36040726\n36040727\n36040728\n36043491\n36043492\n36043493\n36043494\n36048928\n36048929\n36048930\n36048931\n36048932\n36048933\n36048934\n36048935\n36048936\n36048937\n36048938\n36048939\n36055143\n36055144\n36068081\n36068082\n36068083\n36068084\n36068085\n36068086\n36078464\n36078465\n36078466\n36078467\n36078468\n36087121\n36087122\n36087123\n36087124\n36087125\n36087126\n36092012\n36092013\n36219930\n36219931\n36219932\n36219933\n36224134\n36224135\n36224136\n36227992\n36227993\n36227994\n36227995\n36228449\n36228450\n36228451\n36228753\n36228754\n36233439\n36233900\n36256580\n36256581\n36256582\n36256583\n36256584\n36256585\n36256586\n36256587\n36258193\n36258194\n36258195\n36258196\n36261366\n36261367\n36261368\n36261369\n36261370\n36261371\n36261373\n36261374\n36261376\n36266106\n36266107\n36266110\n36266111\n36266112\n36268719\n36269061\n36269062\n36270877\n36270878\n36270879\n36271660\n36271661\n36306519\n36306780\n36306781\n36306782\n36306783\n36306784\n36306785\n36306786\n36311913\n36311914\n36311915\n36311916\n36314781\n36314782\n36314783\n36314784\n36314785\n36314786\n36314787\n36314788\n36315939\n36316920\n36316921\n36316922\n36316923\n36318889\n36318890\n36318891\n36318892\n36318893\n36318894\n36318895\n36318896\n36318897\n36318898\n36320911\n36320912\n36320913\n36320914\n36320915\n36320916\n36322144\n36325066\n36325067\n36325068\n36327346\n36327347\n36327352\n36327358\n36327662\n36369519\n36369780\n36369781\n36378265\n36378266\n36378267\n36378268\n36378269\n36378270\n36378271\n36386880\n36386881\n36386882\n36386883\n36386884\n36386885\n36392438\n36392439\n36392520\n36392521\n36392522\n36396975\n36396976\n36396977\n36396978\n36396979\n36397120\n36413022\n36413024\n36413025\n36413026\n36413027\n36413028\n36413029\n36413030\n36413031\n36413032\n36415159\n36416042\n36416043\n36416044\n36416334\n36416335\n36416336\n36416337\n36416338\n36416339\n36416420\n36422413\n36422414\n36422598\n36422599\n36423963\n36423964\n36423965\n36423995\n36423996\n36447747\n36447748\n36447749\n36448144\n36448145\n36448156\n36448157\n36449975\n36449976\n36449977\n36453798\n36455025\n36455026\n36458843\n36458844\n36458845\n36458846\n36458847\n36480348\n36480349\n36480350\n36480351\n36485714\n36485715\n36485716\n36485717\n36485718\n36485719\n36485800\n36485801\n36485802\n36485803\n36485851\n36485852\n36491169\n36491170\n36491171\n36491172\n36491173\n36491174\n36493672\n36493673\n36493674\n36493675\n36493676\n36493677\n36498253\n36498254\n36498255\n36501125\n36508768\n36508771\n36508772\n36508773\n36508774\n36525439\n36529070\n36529071\n36529072\n36529073\n36529074\n36529075\n36529076\n36529077\n36529078\n36529079\n36535347\n36535348\n36535349\n36535352\n36535353\n36535354\n36535355\n36539304\n36539306\n36545277\n36545278\n36545279\n36545760\n36545761\n36548829\n36548830\n36552374\n36553653\n36553654\n36553655\n36554562\n36554563\n36554564\n36554565\n36554566\n36555138\n36560052\n36560053\n36560054\n36560055\n36560056\n36566126\n36566127\n36566128\n36566129\n36567621\n36571196\n36571197\n36571198\n36571199\n36571780\n36571781\n36572200\n36572201\n36572202\n36572203\n36572204\n36574800\n36574801\n36574802\n36575688\n36575689\n36575690\n36577074\n36577075\n36578325\n36578327\n36578328\n36582969\n36586443\n36618329\n36620780\n36620781\n36620782\n36620783\n36620784\n36620785\n36620786\n36620787\n36620788\n36625778\n36625779\n36626060\n36626061\n36626062\n36626063\n36626064\n36626065\n36626066\n36626067\n36630781\n36630782\n36630783\n36630784\n36630785\n36630786\n36630787\n36630788\n36630789\n36630790\n36645417\n36645418\n36645419\n36673680\n36673681\n36673682\n36673683\n36675542\n36675543\n36675545\n36675546\n36675547\n36675549\n36675550\n36675551\n36675552\n36678442\n36678443\n36678444\n36678445\n36678446\n36678447\n36678448\n36683541\n36688432\n36688433\n36688434\n36712751\n36717343\n36738231\n36738232\n36739201\n36739203\n36739206\n36739207\n36739208\n36739209\n36741080\n36741081\n36742784\n36742785\n36742786\n36742787\n36742788\n36742789\n36748006\n36748007\n36748008\n36749662\n36749663\n36761491\n36761492\n36765445\n36765446\n36767807\n36784206\n36785292\n36785384\n36785385\n36787969\n36787970\n36787971\n36788799\n36792076\n36792077\n36793502\n36793503\n36793678\n36793679\n36795349\n36795350\n36795351\n36799042\n36799043\n36801653\n36803154\n36803155\n36817363\n36818518\n36818519;\n\n9. H965SCH647090\nUDI-DI 08714729263890\nBatches\n35284214\n35284216\n35284217\n35296025\n35296026\n35296027\n35307517\n35309535\n35309536\n35313433\n35313434\n35313435\n35343571\n35376080\n35376081\n35376082\n35376083\n35395628\n35395629\n35395630\n35406003\n35452838\n35471394\n35471395\n35471396\n35471397\n35471398\n35476350\n35476351\n35476352\n35476819\n35476960\n35514613\n35541484\n35541485\n35541486\n35541487\n35542644\n35542645\n35542646\n35542647\n35588888\n35588889\n35588890\n35594003\n35600380\n35600381\n35600716\n35600717\n35600718\n35663304\n35663305\n35663307\n35663958\n35663959\n35664480\n35664482\n35667604\n35749225\n35749227\n35749228\n35778247\n35778248\n35778249\n35778250\n35893582\n35893583\n35928594\n35928595\n35950473\n35950474\n35950475\n35964009\n35964010\n35972012\n35980330\n35980331\n36007692\n36007693\n36007694\n36007695\n36007696\n36018041\n36018042\n36033496\n36033497\n36033498\n36033499\n36033880\n36043497\n36043498\n36043499\n36043780\n36055146\n36055147\n36055785\n36056677\n36078428\n36097193\n36116118\n36116119\n36116120\n36220947\n36322723\n36322724\n36328322\n36328323\n36328324\n36341859\n36342380\n36342381\n36342382\n36342383\n36342384\n36342385\n36342386\n36342387\n36342388\n36347198\n36347199\n36347220\n36347221\n36347222\n36347223\n36347224\n36347225\n36347226\n36357714\n36357715\n36378272\n36378273\n36465500\n36465501\n36469380\n36469381\n36469382\n36475477\n36475478\n36508775\n36508776\n36513257\n36513258\n36513259\n36513760\n36518682\n36518683\n36553656\n36553657\n36553658\n36553659\n36554560\n36563910\n36582970\n36582971\n36582972\n36582973\n36582974\n36595826\n36595828\n36635529\n36635530\n36635531\n36646050\n36646051\n36679165\n36688435\n36712758\n36717344\n36795885\n36817573;\n\n10. H965SCH647120\nUDI-DI 08714729263906\nBatches\n35258269\n35258270\n35258273\n35258274\n35260228\n35260229\n35265522\n35265523\n35266396\n35266397\n35266398\n35266399\n35267871\n35267872\n35272291\n35272292\n35273687\n35273688\n35273689\n35274001\n35274002\n35274003\n35274004\n35276183\n35276184\n35276185\n35276186\n35276187\n35277609\n35278162\n35278163\n35278164\n35278165\n35278167\n35281328\n35281329\n35289305\n35306610\n35306611\n35306612\n35310693\n35310694\n35310695\n35310696\n35315986\n35315987\n35315988\n35320538\n35320539\n35324563\n35324564\n35324565\n35324566\n35324567\n35324568\n35324569\n35376084\n35376085\n35376087\n35380104\n35380105\n35380315\n35380316\n35381858\n35381859\n35381980\n35381981\n35381982\n35381983\n35381984\n35395631\n35395632\n35395633\n35406004\n35406005\n35406007\n35406008\n35406009\n35406010\n35409844\n35409845\n35409847\n35409848\n35409849\n35409851\n35409852\n35409853\n35416153\n35416154\n35452819\n35453000\n35461486\n35480117\n35480118\n35480946\n35480947\n35480948\n35480949\n35484493\n35484494\n35487378\n35487379\n35501516\n35501517\n35514615\n35514616\n35514617\n35515702\n35517161\n35519704\n35545687\n35545688\n35545689\n35545690\n35545691\n35546819\n35547736\n35547737\n35551690\n35551691\n35551692\n35565638\n35565640\n35565641\n35565642\n35565643\n35569825\n35569826\n35569827\n35594002\n35626901\n35665247\n35667601\n35667602\n35671453\n35671454\n35671455\n35671456\n35671457\n35673280\n35890013\n35890014\n35895660\n35895661\n35901388\n35901389\n35921353\n35921354\n35921355\n35921356\n35942368\n35998696\n35998697\n35998698\n36001798\n36001799\n36002640\n36009902\n36009903\n36009904\n36009905\n36012794\n36043495\n36043496\n36056678\n36056679\n36056960\n36056961\n36056964\n36058844\n36058845\n36058846\n36058847\n36063287\n36063288\n36063290\n36068087\n36068088\n36068089\n36068090\n36095403\n36095404\n36095405\n36095406\n36096639\n36101301\n36101302\n36101699\n36102320\n36102321\n36102324\n36102325\n36103434\n36103435\n36103436\n36105447\n36105448\n36111547\n36111548\n36111549\n36111551\n36111552\n36112953\n36112954\n36112955\n36112956\n36112957\n36121884\n36138616\n36138617\n36138800\n36138804\n36138805\n36159666\n36159667\n36159668\n36159669\n36159670\n36159672\n36159673\n36164841\n36164842\n36164843\n36169145\n36169146\n36169147\n36169148\n36169867\n36169868\n36169869\n36173875\n36173876\n36179702\n36179703\n36180136\n36193169\n36193170\n36193171\n36193172\n36193173\n36195518\n36195519\n36195580\n36195581\n36195582\n36205168\n36205169\n36208940\n36208941\n36209024\n36209025\n36209424\n36224696\n36224697\n36234046\n36234047\n36234048\n36498257\n36498258\n36498259\n36501127\n36586444\n36586445\n36586446\n36586447\n36588495\n36588497\n36591213\n36591214\n36593068\n36593069\n36607567\n36640275\n36640276\n36640277\n36679166\n36683542\n36688773\n36688774\n36698998\n36698999\n36711322\n36711323\n36787078\n36789908\n36789909\n36796820\n36800990\n36803152\n36834285;\n\n11. H965SCH647130\nUDI-DI 08714729263913\nBatches\n35258275\n35258276\n35258277\n35258278\n35258279\n35260230\n35260231\n35261618\n35261619\n35264188\n35264189\n35264190\n35264191\n35264192\n35266488\n35266489\n35268647\n35268648\n35278746\n35281326\n35281327\n35285493\n35285494\n35285495\n35285496\n35285497\n35285498\n35285499\n35285920\n35286196\n35286197\n35286198\n35286199\n35286540\n35287317\n35287319\n35287401\n35289015\n35289303\n35293059\n35293160\n35293161\n35293162\n35293163\n35293812\n35293813\n35293815\n35293816\n35320520\n35320521\n35320522\n35320523\n35320525\n35325953\n35325954\n35325955\n35329088\n35329090\n35329091\n35329092\n35329093\n35329094\n35329095\n35329096\n35329544\n35329545\n35329546\n35329547\n35329548\n35329549\n35329968\n35329969\n35329970\n35329971\n35330502\n35336128\n35336129\n35336130\n35336131\n35341680\n35353660\n35353661\n35353662\n35353663\n35353664\n35361464\n35361465\n35361466\n35361467\n35381985\n35382290\n35382291\n35383353\n35383354\n35383355\n35383356\n35383357\n35383358\n35383359\n35383620\n35383622\n35383623\n35386372\n35386373\n35386374\n35409855\n35409856\n35409857\n35409858\n35416156\n35416157\n35416158\n35416159\n35416460\n35416461\n35416462\n35416463\n35416464\n35416465\n35416466\n35416467\n35416468\n35416469\n35416470\n35422921\n35422928\n35422929\n35422930\n35424325\n35424326\n35424327\n35424328\n35424329\n35424330\n35424331\n35424332\n35424333\n35424335\n35424336\n35424337\n35424338\n35424339\n35428634\n35428635\n35428636\n35428637\n35428638\n35428639\n35438650\n35438651\n35461489\n35462384\n35462385\n35462386\n35462387\n35462388\n35480950\n35480951\n35480952\n35480953\n35480955\n35480956\n35484496\n35484497\n35484498\n35501518\n35501519\n35501920\n35501921\n35501922\n35501923\n35525176\n35525177\n35525806\n35525807\n35530632\n35530633\n35530634\n35531679\n35531880\n35533597\n35533598\n35533599\n35534100\n35534101\n35534102\n35553908\n35553909\n35553910\n35553911\n35553937\n35553938\n35556848\n35556849\n35569824\n35570978\n35570979\n35571040\n35571538\n35571539\n35574379\n35574500\n35574501\n35574502\n35574503\n35578673\n35578674\n35578675\n35594949\n35623467\n35623468\n35626636\n35626637\n35626638\n35626639\n35626900\n35627523\n35627524\n35630022\n35630023\n35632452\n35632454\n35632455\n35632638\n35632639\n35633487\n35633492\n35633901\n35633903\n35636548\n35636549\n35636550\n35636551\n35667603\n35668453\n35668454\n35671444\n35671445\n35671447\n35671448\n35671449\n35673282\n35673283\n35677031\n35777662\n35777664\n35781899\n35782160\n35782161\n35782162\n35782163\n35782164\n35873344\n35873345\n35881810\n35881811\n35881812\n35881813\n35884601\n35884602\n35890010\n35901386\n35901387\n35904064\n35904065\n35942369\n35964011\n35964012\n35964013\n35964014\n35985601\n35985602\n36012795\n36012796\n36012797\n36012798\n36012799\n36012980\n36032984\n36068091\n36068092\n36105449\n36105450\n36105451\n36106593\n36106594\n36106595\n36106596\n36109872\n36109874\n36111550\n36116121\n36116122\n36116123\n36119507\n36119508\n36121880\n36121881\n36121882\n36121885\n36121886\n36124483\n36124484\n36130876\n36130877\n36130878\n36130879\n36131000\n36132932\n36132933\n36132934\n36132935\n36132936\n36132937\n36144149\n36144150\n36144151\n36144152\n36144153\n36144154\n36144155\n36144156\n36148525\n36148526\n36148823\n36148825\n36148827\n36148829\n36148830\n36154096\n36154097\n36154098\n36154099\n36154980\n36154981\n36154982\n36154983\n36154984\n36154985\n36154987\n36164844\n36164845\n36164846\n36164847\n36173877\n36173878\n36173879\n36174740\n36174741\n36174742\n36174743\n36174744\n36180137\n36180138\n36185918\n36185919\n36186400\n36186401\n36186402\n36186403\n36187901\n36187903\n36187904\n36187905\n36187906\n36194716\n36195042\n36200119\n36200760\n36202408\n36202409\n36205165\n36205166\n36212469\n36214814\n36214815\n36214816\n36219092\n36219093\n36219094\n36219095\n36219096\n36422415\n36422416\n36422417\n36516037\n36516038\n36516039\n36518684\n36518685\n36518686\n36518687\n36518688\n36518689\n36518690\n36518691\n36518693\n36520868\n36593070\n36593071\n36595822\n36595823\n36595824\n36595825\n36597571\n36597572\n36597573\n36597574\n36603361\n36603364\n36603365\n36603366\n36605707\n36606062\n36606063\n36606064\n36606065\n36606066\n36606067\n36606068\n36606069\n36640278\n36640279\n36641940\n36641941\n36642785\n36644287\n36644288\n36644752\n36644753\n36644754\n36664959\n36664987\n36664990\n36666077\n36666520\n36666522\n36666524\n36669032\n36669035\n36669036\n36669037\n36699060\n36699061\n36700303\n36712756\n36717599\n36717900\n36717901\n36717902\n36717903\n36717904\n36722328\n36722330\n36750320\n36750321\n36750322\n36750323\n36750324\n36752754\n36752755\n36752756\n36752758\n36752759\n36752900\n36766975\n36766976\n36766977\n36768310\n36768752\n36768753\n36773943\n36795889\n36795890\n36800991\n36800992\n36803691\n36804582\n36811474\n36811478\n36811479\n36812060\n36813561\n36813562\n36815619\n36815667\n36817342\n36844079;\n\n12. H965SCH647140\nUDI-DI 08714729263920\nBatches\n35272289\n35272290\n35278747\n35278748\n35293817\n35293818\n35293819\n35309703\n35309704\n35309705\n35309706\n35320537\n35329976\n35329978\n35329979\n35341681\n35341682\n35344559\n35345321\n35345329\n35347267\n35347268\n35347269\n35383621\n35386679\n35386780\n35386781\n35388276\n35388277\n35428800\n35428801\n35428802\n35428803\n35484499\n35489527\n35489530\n35489533\n35496534\n35496535\n35496536\n35525178\n35530635\n35560220\n35560221\n35560222\n35566231\n35625591\n35625592\n35641157\n35641460\n35677035\n35677036\n35677037\n35677038\n35682786\n35682787\n35682788\n35682789\n35682790\n35682791\n35778251\n35778252\n35987778\n35987779\n36066437\n36066438\n36072052\n36072851\n36072852\n36072854\n36105453\n36115283\n36115284\n36124482\n36132938\n36132939\n36133160\n36134809\n36154986\n36159663\n36164696\n36164697\n36164698\n36164699\n36179704\n36179705\n36179706\n36195056\n36202763\n36205164\n36213495\n36213496\n36213572\n36213573\n36213574\n36213575\n36498341\n36501128\n36501129\n36606591\n36652845\n36652846\n36773180\n36773181\n36773182\n36775992\n36775994\n36818514\n36818515;\n\n13. M001719000\nUDI-DI 08714729781165\nBatches\n35438655\n35438656\n35438657\n35641993\n35641994\n36053998\n36053999\n36223361\n36223362\n36348206\n36523368\n36616127\n36777256\n\n14. M001719010\nUDI-DI 08714729781189\nBatches\n35252807\n35307515\n35307516\n35355536\n35450114\n35450115\n35504179\n35504200\n35504201\n35571041\n35583635\n35583636\n35583637\n36223363\n36223364\n36224129\n36224132\n36224133\n36230818\n36297515\n36297516\n36297518\n36297761\n36368141\n36368142\n36412855\n36475475\n36539307\n36616133\n36616134\n36739202\n\n15. M001719020\nUDI-DI 08714729781202\nBatches\n35252812\n35343568\n35343569\n35343570\n35343572\n35355537\n35379661\n35406002\n35476349\n35480115\n35480116\n35542648\n35560230\n35560231\n35629995\n35629996\n35629997\n35636546\n35636547\n35662002\n35662003\n35961401\n35961402\n35961403\n35961404\n35961405\n35970484\n35972013\n35977619\n36006440\n36007615\n36007616\n36007618\n36271662\n36271663\n36271664\n36271665\n36271666\n36275712\n36275713\n36275714\n36275715\n36275716\n36299150\n36299151\n36299152\n36299153\n36299154\n36306787\n36306788\n36397121\n36397122\n36453791\n36453792\n36453793\n36453795\n36475476\n36552375\n36552376\n36565457\n36617888\n36630791\n36633072\n36635526\n36767805\n36767806;\n\n16. M001719030\nUDI-DI 08714729781226\nBatches\n35343573\n35347264\n35379662\n35476961\n35476962\n35545686\n35550309\n35550605\n35589532\n35664483\n35749224\n35980332\n35980333\n35997086\n36018043\n36078429\n36087098\n36087099\n36087540\n36096632\n36096633\n36347227\n36397123\n36416430\n36416431\n36563911\n36565458\n36565459\n36635532\n36635533;\n\n17. M001719040\nUDI-DI 08714729781103\nBatches\n35281323\n35281324\n35281325\n35324570\n35324571\n35416155\n35484495\n35547738\n35623469\n36113886\n36113887\n36115281\n36115282\n36124259\n36124480\n36124481\n36169150\n36209425\n36498340\n36711739\n36712757\n36713869;\n\n18. M001719050\nUDI-DI 08714729781127\nBatches\n35293814\n35295923\n35347265\n35347266\n35388278\n35485560\n35553939\n35641991\n35682792\n35939213\n35939214\n35939215\n35939216\n36065524\n36065525\n36065526\n36148529\n36148532\n36508770\n36606592\n36771557\n36817706;\n\n19. M001719060\nUDI-DI 08714729781141\nBatches\n35310697\n35315981\n35315982\n35347270\n35388279\n35496537\n35566234\n35682793\n35978123\n36043781\n36105452\n36159664\n36159665\n36164840\n36498342", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "Clara Johnson\n763-494-1700", "reason_for_recall": "Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful stent deployment. The most serious potential adverse health consequence is stroke. Other risks include delay to procedure, vessel injury, vessel spasm, or stent disruption/damage necessitating additional intervention.", "root_cause_description": "Process change control", "action": "On July 7, 2025, the firm sent \"Urgent Medical Device Removal\" customer notifications to all affected accounts either via FedEx Overnight Delivery or in person delivery by sales representatives. The letter provided customers with information about identifying the product and instructions for product segregation and return. \n\n1. Further distribution or use of any remaining devices (Attachment 1) affected by this \nremoval should cease immediately.\nDo NOT use affected devices and remove those devices from your facility s inventory. Segregate the units in a secure place until they can be returned to Boston Scientific.\n2. Immediately post this information in a visible location near the affected devices to ensure it is readily accessible to all handlers and users of the device. \n3. Forward this notice to any healthcare professional from your organization and to any facilities where affected devices have been transferred, including hospitals or sites within your network.\nIf you are a distributor, this notice must be forwarded to your customers to ensure notification of this device removal is carried out to the end-user level. \n4. Complete and return the enclosed Reply Verification Tracking Form via email: BSCFieldActionCenter@bsci.com or fax: BSC Field Action Center 1-763-415-7708.\n5. Return affected devices to Boston Scientific.\n\nIf you have any questions, call the Quality Systems Manager II at 763-494-1700.", "product_quantity": "26,570 (1,333 US; 25,174 OUS)", "distribution_pattern": "Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.", "openfda": { "pma_number": [ "P070012", "P030047", "P240029", "P050025", "P240009", "P060001", "P040012", "P180010", "P050019", "P040038", "P140026", "P210030" ], "registration_number": [ "3004091615", "3011471056", "3022627847", "2011171", "1016427", "1424778", "3013556777", "3002807314", "2124215", "2024024", "9681260", "2183744", "2024168", "3012865735", "9616099", "3010079067", "3010432890", "1643817", "3003956144", "3009756327", "3015192261", "2183870", "3031658894", "2939561", "3010173425" ], "fei_number": [ "3002807036", "3004091615", "3011471056", "3022627847", "2011171", "1016427", "3013556777", "3002807314", "2124215", "2024024", "2183744", "2024168", "3012865735", "3004635528", "3003473227", "3010079067", "3010432890", "3002806565", "1643817", "3003956144", "3003528016", "3015192261", "3002807038", "2183870", "3031658894" ], "device_name": "Stent, Carotid", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }