United StatesAutomated Impella Controller (AIC) consoles are affected; look for Product Codes 0042-0000-CA, 0042-0000-EU, 0042-0000-UK, or 0042-0000-US and the listed GTINs and serial numbers. The recall cites alarm failures, power-path faults, electrical-short risks, inaccurate motor-current sensing, and improper purge cassette alignment that can cause a piston block event and prevent completion of purge priming, potentially requiring use of a backup AIC console.
What's being recalled
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US.
Recalling firm: Abiomed, Inc., Danvers, MA, United States.
How to identify it
1. Product Code: 0042-0000-CA. GTIN: 00813502011272. Serial Numbers: IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715. 2. Product Code: 0042-0000-EU. GTIN: 00813502011289. Serial Numbers: IC1217, IC1265, IC1275, IC1276, IC1288, IC1284, IC1301, IC1302, IC1304, IC1305, IC1344, IC1341, IC1343, IC1340, IC1345, IC1350, IC1347, IC1349, IC1383, IC1381, IC1384, IC1386, IC1393, IC1396, IC1397, IC1395, IC1413, IC1415, IC1411, IC1416, IC1490, IC1488, IC1522, IC1523, IC1524, IC1525, IC1547, IC1549, IC1546, IC1548, IC1578, IC1577, IC1579, IC1580, IC1594, IC1584, IC1590, IC1592, IC1591, IC1585, IC1588, IC1653, IC1676, IC1685, IC1684, IC1677, IC1678, IC1699, IC1700. 3. Product Code: 0042-0000-UK. GTIN: 00813502011296. Serial Numbers: IC1387, IC1389, IC1388, IC1519, IC1542, IC1545, IC1581, IC1582, IC1583, IC1573. 4. Product Code: 0042-0000-US. GTIN: 00813502010022. Serial Numbers: IC1004, IC1002, IC1001, IC1006, IC1007, IC1008, IC1014, IC1015, IC1017, IC1019, IC1024, IC1025, IC1028, IC1029, IC1026, IC1027, IC1033, IC1035, IC1031, IC1032, IC1036, IC1037, IC1038, IC1039, IC1041, IC1042, IC1044, IC1049, IC1043, IC1046, IC1053, IC1055, IC1052, IC1040, IC1030, IC1056, IC1047, IC1051, IC1050, IC1060, IC1061, IC1062, IC1064, IC1065, IC1066, IC1067, IC1074, IC1070, IC1071, IC1072, IC1073, IC1068, IC1069, IC1058, IC1075, IC1076, IC1077, IC1078, IC1079, IC1084, IC1085, IC1083, IC1080, IC1088, IC1086, IC1087, IC1081, IC1082, IC1100, IC1099, IC1093, IC1095, IC1089, IC1094, IC1096, IC1097, IC1106, IC1102, IC1105, IC1104, IC1108, IC1103, IC1107, IC1110, IC1115, IC1120, IC1111, IC1112, IC1114, IC1116, IC1117, IC1119, IC1133, IC1113, IC1132, IC1124, IC1134, IC1135, IC1136, IC1137, IC1138, IC1140, IC1141, IC1142, IC1139, IC1144, IC1143, IC1121, IC1122, IC1123, IC1147, IC1148, IC1145, IC1146, IC1149, IC1150, IC1151, IC1152, IC1153, IC1154, IC1157, IC1158, IC1159, IC1156, IC1162, IC1163, IC1164, IC1165, IC1166, IC1167, IC1168, IC1169, IC1170, IC1171…
The hazard
Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Denmark, France, Germany, Italy, Kuwait, Netherlands, Norway, Saudi Arabia, Spain, Switzerland, United Arab Emirates, United Kingdom.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)