{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "65567", "product_res_number": "Z-0212-2008", "event_date_initiated": "2007-10-19", "event_date_posted": "2007-11-21", "recall_status": "Terminated", "event_date_terminated": "2009-05-26", "res_event_number": "45486", "product_code": "DSQ", "pma_numbers": [ "P870072S027" ], "product_description": "Thoratec Implantable Ventricular Assist Device (IVAD pump)\n(Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588", "code_info": "Catalog No. 10012-2555-001 Codes: (Serial Numbers 488 or higher and manufactured and distributed since October 2004)  488--\t621\t669\t729\t781\t908\t956\t1013\t1060\t1118\t1166\t1219\t1316\t1364\t1412\t1459\t1506\t1576 489--\t622\t670\t730\t782\t909\t957\t1014\t1061\t1119\t1167\t1220\t1317\t1365\t1413\t1460\t1507\t1577 502--\t623\t671\t731\t783\t910\t958\t1015\t1062\t1120\t1168\t1221\t1318\t1366\t1414\t1461\t1508\t1578 503--\t624\t672\t733\t784\t911\t959\t1016\t1063\t1121\t1169\t1222\t1319\t1367\t1415\t1462\t1509\t1579 504--\t625\t673\t734\t785\t912\t960\t1017\t1064\t1122\t1170\t1223\t1320\t1368\t1416\t1463\t1510\t1580 505--\t626\t674\t735\t786\t913\t961\t1018\t1065\t1123\t1171\t1224\t1321\t1369\t1417\t1464\t1511\t1581 506--\t627\t675\t736\t787\t914\t962\t1019\t1066\t1124\t1173\t1225\t1323\t1370\t1418\t1465\t1512\t1582 507--\t628\t676\t737\t788\t915\t963\t1020\t1067\t1125\t1174\t1226\t1324\t1371\t1419\t1466\t1513\t1583 508--\t629\t677\t739\t789\t916\t964\t1021\t1068\t1126\t1175\t1227\t1325\t1372\t1420\t1467\t1514\t1584 509--\t630\t678\t740\t790\t917\t965\t1022\t1069\t1127\t1176\t1228\t1326\t1374\t1421\t1468\t1515\t1585 511--\t631\t679\t741\t791\t918\t966\t1023\t1070\t1128\t1177\t1229\t1327\t1375\t1422\t1469\t1516\t1586 512--\t632\t680\t742\t792\t919\t967\t1024\t1071\t1129\t1178\t1230\t1328\t1376\t1423\t1470\t1517\t1587 513--\t633\t681\t743\t793\t920\t968\t1025\t1072\t1130\t1179\t1231\t1329\t1377\t1424\t1471\t1518\t1588 514--\t634\t682\t744\t794\t921\t969\t1026\t1073\t1131\t1180\t1232\t1330\t1378\t1425\t1472\t1519\t1589 515--\t635\t683\t746\t795\t922\t970\t1027\t1074\t1132\t1181\t1233\t1331\t1379\t1426\t1473\t1520\t1590 516--\t636\t684\t747\t796\t923\t971\t1028\t1075\t1133\t1182\t1234\t1332\t1380\t1427\t1474\t1521\t1591 517--\t637\t685\t748\t797\t924\t972\t1029\t1076\t1134\t1183\t1235\t1333\t1381\t1428\t1475\t1522\t1592 518--\t638\t686\t749\t798\t925\t973\t1030\t1077\t1135\t1188\t1236\t1334\t1382\t1429\t1476\t1523\t1593 520--\t639\t687\t751\t799\t926\t974\t1031\t1078\t1136\t1189\t1237\t1335\t1383\t1430\t1477\t1524\t1594 521--\t640\t688\t752\t800\t927\t975\t1032\t1079\t1137\t1190\t1238\t1336\t1384\t1431\t1478\t1525\t1595 522--\t641\t689\t753\t801\t928\t976\t1033\t1080\t1138\t1191\t1239\t1337\t1385\t1432\t1479\t1526\t1596 523--\t642\t701\t754\t802\t929\t977\t1034\t1081\t1139\t1192\t1240\t1338\t1386\t1433\t1480\t1527\t1597 524--\t643\t702\t755\t803\t930\t978\t1035\t1082\t1140\t1193\t1241\t1339\t1387\t1434\t1481\t1528\t 525--\t644\t704\t756\t804\t931\t979\t1036\t1083\t1141\t1194\t1242\t1340\t1388\t1435\t1482\t1529\t 526--\t645\t705\t757\t805\t932\t980\t1037\t1084\t1142\t1195\t1243\t1341\t1389\t1436\t1483\t1530\t 527--\t646\t706\t759\t806\t933\t981\t1038\t1085\t1143\t1196\t1244\t1342\t1390\t1437\t1484\t1531\t 528--\t647\t707\t760\t807\t934\t982\t1039\t1086\t1144\t1197\t1246\t1343\t1391\t1438\t1485\t1550\t 529--\t649\t708\t761\t808\t935\t983\t1040\t1087\t1145\t1198\t1247\t1344\t1392\t1439\t1486\t1551\t 601--\t650\t709\t762\t809\t936\t984\t1041\t1088\t1146\t1199\t1248\t1345\t1393\t1440\t1487\t1552\t 602--\t651\t710\t763\t810\t937\t985\t1042\t1089\t1147\t1201\t1249\t1346\t1394\t1441\t1488\t1553\t 603--\t652\t711\t764\t811\t938\t986\t1043\t1090\t1148\t1202\t1250\t1347\t1395\t1442\t1489\t1554\t 604--\t653\t712\t765\t812\t939\t987\t1044\t1102\t1149\t1203\t1251\t1348\t1396\t1443\t1490\t1555\t 605--\t654\t713\t766\t813\t940\t988\t1045\t1103\t1150\t1204\t1301\t1349\t1397\t1444\t1491\t1556\t 606--\t655\t714\t767\t814\t941\t989\t1046\t1104\t1151\t1205\t1302\t1350\t1398\t1445\t1492\t1557\t 607--\t656\t715\t768\t815\t943\t990\t1047\t1105\t1152\t1206\t1303\t1351\t1399\t1446\t1493\t1558\t 608--\t657\t716\t769\t816\t944\t1001\t1048\t1106\t1153\t1207\t1304\t1352\t1400\t1447\t1494\t1559\t 609--\t658\t718\t770\t817\t945\t1002\t1049\t1107\t1154\t1208\t1305\t1353\t1401\t1448\t1495\t1560\t 610--\t659\t719\t771\t818\t946\t1003\t1050\t1108\t1155\t1209\t1306\t1354\t1402\t1449\t1496\t1561\t 611--\t660\t720\t772\t819\t947\t1004\t1051\t1109\t1156\t1210\t1307\t1355\t1403\t1450\t1497\t1563\t 612--\t661\t721\t773\t820\t948\t1005\t1052\t1110\t1158\t1211\t1308\t1356\t1404\t1451\t1498\t1564\t 613--\t662\t722\t774\t901\t949\t1006\t1053\t1111\t1159\t1212\t1309\t1357\t1405\t1452\t1499\t1565\t 614--\t663\t723\t775\t902\t950\t1007\t1054\t1112\t1160\t1213\t1310\t1358\t1406\t1453\t1500\t1566\t 615--\t664\t724\t776\t903\t951\t1008\t1055\t1113\t1161\t1214\t1311\t1359\t1407\t1454\t1501\t1570\t 616--\t665\t725\t777\t904\t952\t1009\t1056\t1114\t1162\t1215\t1312\t1360\t1408\t1455\t1502\t1571\t 617--\t666\t726\t778\t905\t953\t1010\t1057\t1115\t1163\t1216\t1313\t1361\t1409\t1456\t1503\t1573\t 618--\t667\t727\t779\t906\t954\t1011\t1058\t1116\t1164\t1217\t1314\t1362\t1410\t1457\t1504\t1574\t 619--\t668\t728\t780\t907\t955\t1012\t1059\t1117\t1165\t1218\t1315\t1363\t1411\t1458\t1505\t1575", "firm_fei_number": "2916596", "recalling_firm": "Thoratec Corp", "address_1": "6035 Stoneridge Drive", "city": "Pleasanton", "state": "CA", "postal_code": "94588", "additional_info_contact": "925-847-8600", "reason_for_recall": "Pneumatic Leaks: air leaks developing in the pneumatic driveline when subjected to excessive stress at the junction of the percutaneous line to the pump housing due to sharp bending when implanted (paracorporeal-external-position).", "root_cause_description": "Device Design", "action": "An initial communication was sent to all affected IVAD customers on October 19, 2007, in the form of an \"Urgent: Medical Device Correction\" notice informing them of the problem. The correction notice requests that its customers/physicians take the following actions:\n1) Contact all ongoing patients with IVADs placed in the paracorporeal position to\nevaluate the percutaneous line adjacent to the pump housing to ensure that it is not subject to extreme flexing or bending at acute angles. 2) Remind implanting surgeons and support staff of proper percutaneous line management and provide the patient with a copy of the recall information provided. Complete and sign an Acknowledgement form and fax it to Thoratec Regulatory Affairs. This is a User Level Recall. The firm also issued a November 7, 2007, Press Statement- Urgent Thoratec Corporation Worldwide Recall of Implantable Ventricular Assist Device.", "product_quantity": "766", "distribution_pattern": "Worldwide: USA including states of AL,AR,AZ,CA,CO, FL,GA, IA,IL, IN,KS,KY,LA, MA, MD, ME,MI, MN, MO,NC, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI and to the following countries: Austria, Canada, France, Netherlands, Singapore, Switzerland, and The United Kingdom", "openfda": { "device_name": "Ventricular (Assist) Bypass", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P170038", "P920014", "P870072", "P160035", "P900023", "P100047", "P160054", "P980012", "P060040" ], "registration_number": [ "2029275", "9612515", "3010163695", "1721676", "1218444", "3008454189", "2031044", "2134470", "1927395", "2916596", "3005228872", "3007042319", "3012931014", "3008792657", "1319639", "2528981", "2182208", "3019807891", "3002807090", "3011823740", "3004582654", "2133810", "3003306248" ], "fei_number": [ "3001236763", "1000138054", "3010163695", "1721676", "1218444", "3000203066", "3008454189", "1927395", "2916596", "1000306431", "3005228872", "3007042319", "3012931014", "3008792657", "2528981", "3002462840", "2182208", "3019807891", "3011823740", "3004582654", "3002808437", "3006003617", "3003306248" ] } } ] }