• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall Thoratec Implantable Ventricular Assist Device (IVAD)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 1 Recall
Thoratec Implantable Ventricular Assist Device (IVAD)
see related information
Date Posted November 21, 2007
Recall Status1 Terminated on May 26, 2009
Recall Number Z-0212-2008
Recall Event ID 45486
Premarket Approval
PMA Number
P870072/S027
Product Classification Ventricular (Assisst) Bypass - Product Code DSQ
Product Thoratec Implantable Ventricular Assist Device (IVAD pump) (Component of Thoratec Ventricular Assist Device (VAD) System), Catalog No. 10012-2555-001 ,Thoratec Corporation, Pleasanton, CA. 94588
Code Information Catalog No. 10012-2555-001 Codes: (Serial Numbers 488 or higher and manufactured and distributed since October 2004) 488-- 621 669 729 781 908 956 1013 1060 1118 1166 1219 1316 1364 1412 1459 1506 1576 489-- 622 670 730 782 909 957 1014 1061 1119 1167 1220 1317 1365 1413 1460 1507 1577 502-- 623 671 731 783 910 958 1015 1062 1120 1168 1221 1318 1366 1414 1461 1508 1578 503-- 624 672 733 784 911 959 1016 1063 1121 1169 1222 1319 1367 1415 1462 1509 1579 504-- 625 673 734 785 912 960 1017 1064 1122 1170 1223 1320 1368 1416 1463 1510 1580 505-- 626 674 735 786 913 961 1018 1065 1123 1171 1224 1321 1369 1417 1464 1511 1581 506-- 627 675 736 787 914 962 1019 1066 1124 1173 1225 1323 1370 1418 1465 1512 1582 507-- 628 676 737 788 915 963 1020 1067 1125 1174 1226 1324 1371 1419 1466 1513 1583 508-- 629 677 739 789 916 964 1021 1068 1126 1175 1227 1325 1372 1420 1467 1514 1584 509-- 630 678 740 790 917 965 1022 1069 1127 1176 1228 1326 1374 1421 1468 1515 1585 511-- 631 679 741 791 918 966 1023 1070 1128 1177 1229 1327 1375 1422 1469 1516 1586 512-- 632 680 742 792 919 967 1024 1071 1129 1178 1230 1328 1376 1423 1470 1517 1587 513-- 633 681 743 793 920 968 1025 1072 1130 1179 1231 1329 1377 1424 1471 1518 1588 514-- 634 682 744 794 921 969 1026 1073 1131 1180 1232 1330 1378 1425 1472 1519 1589 515-- 635 683 746 795 922 970 1027 1074 1132 1181 1233 1331 1379 1426 1473 1520 1590 516-- 636 684 747 796 923 971 1028 1075 1133 1182 1234 1332 1380 1427 1474 1521 1591 517-- 637 685 748 797 924 972 1029 1076 1134 1183 1235 1333 1381 1428 1475 1522 1592 518-- 638 686 749 798 925 973 1030 1077 1135 1188 1236 1334 1382 1429 1476 1523 1593 520-- 639 687 751 799 926 974 1031 1078 1136 1189 1237 1335 1383 1430 1477 1524 1594 521-- 640 688 752 800 927 975 1032 1079 1137 1190 1238 1336 1384 1431 1478 1525 1595 522-- 641 689 753 801 928 976 1033 1080 1138 1191 1239 1337 1385 1432 1479 1526 1596 523-- 642 701 754 802 929 977 1034 1081 1139 1192 1240 1338 1386 1433 1480 1527 1597 524-- 643 702 755 803 930 978 1035 1082 1140 1193 1241 1339 1387 1434 1481 1528 525-- 644 704 756 804 931 979 1036 1083 1141 1194 1242 1340 1388 1435 1482 1529 526-- 645 705 757 805 932 980 1037 1084 1142 1195 1243 1341 1389 1436 1483 1530 527-- 646 706 759 806 933 981 1038 1085 1143 1196 1244 1342 1390 1437 1484 1531 528-- 647 707 760 807 934 982 1039 1086 1144 1197 1246 1343 1391 1438 1485 1550 529-- 649 708 761 808 935 983 1040 1087 1145 1198 1247 1344 1392 1439 1486 1551 601-- 650 709 762 809 936 984 1041 1088 1146 1199 1248 1345 1393 1440 1487 1552 602-- 651 710 763 810 937 985 1042 1089 1147 1201 1249 1346 1394 1441 1488 1553 603-- 652 711 764 811 938 986 1043 1090 1148 1202 1250 1347 1395 1442 1489 1554 604-- 653 712 765 812 939 987 1044 1102 1149 1203 1251 1348 1396 1443 1490 1555 605-- 654 713 766 813 940 988 1045 1103 1150 1204 1301 1349 1397 1444 1491 1556 606-- 655 714 767 814 941 989 1046 1104 1151 1205 1302 1350 1398 1445 1492 1557 607-- 656 715 768 815 943 990 1047 1105 1152 1206 1303 1351 1399 1446 1493 1558 608-- 657 716 769 816 944 1001 1048 1106 1153 1207 1304 1352 1400 1447 1494 1559 609-- 658 718 770 817 945 1002 1049 1107 1154 1208 1305 1353 1401 1448 1495 1560 610-- 659 719 771 818 946 1003 1050 1108 1155 1209 1306 1354 1402 1449 1496 1561 611-- 660 720 772 819 947 1004 1051 1109 1156 1210 1307 1355 1403 1450 1497 1563 612-- 661 721 773 820 948 1005 1052 1110 1158 1211 1308 1356 1404 1451 1498 1564 613-- 662 722 774 901 949 1006 1053 1111 1159 1212 1309 1357 1405 1452 1499 1565 614-- 663 723 775 902 950 1007 1054 1112 1160 1213 1310 1358 1406 1453 1500 1566 615-- 664 724 776 903 951 1008 1055 1113 1161 1214 1311 1359 1407 1454 1501 1570 616-- 665 725 777 904 952 1009 1056 1114 1162 1215 1312 1360 1408 1455 1502 1571 617-- 666 726 778 905 953 1010 1057 1115 1163 1216 1313 1361 1409 1456 1503 1573 618-- 667 727 779 906 954 1011 1058 1116 1164 1217 1314 1362 1410 1457 1504 1574 619-- 668 728 780 907 955 1012 1059 1117 1165 1218 1315 1363 1411 1458 1505 1575
Recalling Firm/
Manufacturer
Thoratec Corp
6035 Stoneridge Drive
Pleasanton, California 94588
Manufacturer 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).
FDA Determined
Cause 2
DESIGN: 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: 1) Contact all ongoing patients with IVADs placed in the paracorporeal position to evaluate 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.
Quantity in Commerce 766
Distribution 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
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = DSQ and Applicant = THORATEC CORP.
-
-