Abiomed, Inc. recalls Automated Impella Controller (AIC) with the below product descriptions and correspondin…
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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.
Lot / code information
- GTIN
- 00813502011272
- Serial #
- IC1324, IC1346, IC1480, IC1481, IC1543, IC1544, IC1572, IC1595, IC1598, IC1664, IC1665, IC1715. 2. Product Code: 0042-0000-EU
- GTIN
- 00813502011289
- Serial #
IC1217, IC1265, IC1275, IC1276, IC1288, IC1284 — +53 moreShow all
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 #
- IC1387, IC1389, IC1388, IC1519, IC1542, IC1545, IC1581, IC1582, IC1583, IC1573. 4. Product Code: 0042-0000-US
- GTIN
- 00813502010022
- Serial #
IC1004, IC1002, IC1001, IC1006, IC1007, IC1008 — +538 moreShow all
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, IC1174, IC1175, IC1172, IC1173, IC1178, IC1160, IC1176, IC1177, IC1179, IC1180, IC1181, IC1182, IC1186, IC1155, IC1183, IC1185, IC1184, IC1187, IC1191, IC1188, IC1189, IC1161, IC1190, IC1192, IC1193, IC1196, IC1219, IC1218, IC1194, IC1197, IC1198, IC1199, IC1213, IC1222, IC1226, IC1221, IC1225, IC1214, IC1220, IC1223, IC1224, IC1227, IC1211, IC1212, IC1208, IC1210, IC1215, IC1209, IC1202, IC1201, IC1200, IC1207, IC1203, IC1205, IC1206, IC1204, IC1235, IC1234, IC1228, IC1230, IC1231, IC1233, IC1229, IC1236, IC1237, IC1238, IC1239, IC1240, IC1242, IC1244, IC1245, IC1243, IC1250, IC1247, IC1258, IC1246, IC1251, IC1252, IC1254, IC1256, IC1257, IC1253, IC1255, IC1261, IC1264, IC1259, IC1262, IC1263, IC1269, IC1274, IC1272, IC1270, IC1271, IC1273, IC1291, IC1300, IC1296, IC1297, IC1289, IC1290, IC1293, IC1298, IC1299, IC1295, IC1292, IC1294, IC1306, IC1310, IC1309, IC1307, IC1311, IC1313, IC1314, IC1312, IC1315, IC1316, IC1317, IC1319, IC1321, IC1320, IC1322, IC1325, IC1331, IC1328, IC1330, IC1332, IC1326, IC1327, IC1333, IC1336, IC1329, IC1335, IC1342, IC1338, IC1339, IC1337, IC1334, IC1358, IC1356, IC1357, IC1353, IC1354, IC1355, IC1351, IC1352, IC1364, IC1365, IC1360, IC1361, IC1362, IC1363, IC1359, IC1379, IC1377, IC1380, IC1375, IC1376, IC1372, IC1374, IC1378, IC1373, IC1382, IC1390, IC1400, IC1408, IC1406, IC1409, IC1394, IC1403, IC1401, IC1405, IC1407, IC1402, IC1404, IC1410, IC1412, IC1414, IC1417, IC1418, IC1421, IC1422, IC1423, IC1419, IC1420, IC1425, IC1426, IC1431, IC1424, IC1429, IC1427, IC1430, IC1428, IC1440, IC1441, IC1434, IC1435, IC1436, IC1437, IC1442, IC1443, IC1432, IC1433, IC1438, IC1439, IC1450, IC1446, IC1448, IC1368, IC1444, IC1445, IC1449, IC1462, IC1461, IC1469, IC1466, IC1467, IC1470, IC1473, IC1474, IC1475, IC1465, IC1453, IC1454, IC1460, IC1471, IC1472, IC1459, IC1463, IC1464, IC1455, IC1458, IC1451, IC1452, IC1456, IC1457, IC1478, IC1484, IC1485, IC1476, IC1477, IC1479, IC1483, IC1482, IC1489, IC1491, IC1492, IC1486, IC1496, IC1495, IC1507, IC1513, IC1505, IC1506, IC1512, IC1514, IC1510, IC1497, IC1499, IC1517, IC1518, IC1515, IC1516, IC1508, IC1501, IC1502, IC1503, IC1504, IC1500, IC1509, IC1498, IC1536, IC1532, IC1531, IC1533, IC1540, IC1538, IC1529, IC1541, IC1537, IC1539, IC1527, IC1526, IC1534, IC1535, IC1528, IC1530, IC1557, IC1556, IC1550, IC1553, IC1554, IC1552, IC1555, IC1551, IC1562, IC1563, IC1564, IC1566, IC1567, IC1568, IC1569, IC1570, IC1571, IC1565, IC1575, IC1558, IC1559, IC1560, IC1561, IC1574, IC1599, IC1603, IC1604, IC1605, IC1596, IC1618, IC1600, IC1601, IC1602, IC1606, IC1607, IC1608, IC1609, IC1610, IC1612, IC1613, IC1614, IC1615, IC1616, IC1617, IC1628, IC1621, IC1622, IC1623, IC1624, IC1625, IC1626, IC1627, IC1639, IC1637, IC1638, IC1629, IC1630, IC1640, IC1631, IC1632, IC1633, IC1634, IC1635, IC1636, IC1648, IC1642, IC1650, IC1644, IC1645, IC1646, IC1651, IC1652, IC1641, IC1643, IC1663, IC1654, IC1655, IC1660, IC1661, IC1662, IC1656, IC1657, IC1658, IC1659, IC1674, IC1666, IC1669, IC1673, IC1672, IC1670, IC1671, IC1675, IC1668, IC1686, IC1679, IC1680, IC1681, IC1682, IC1683, IC1694, IC1692, IC1693, IC1697, IC1698, IC1695, IC1696, IC1687, IC1688, IC1689, IC1690, IC1691, IC1701, IC1705, IC1704, IC1708, IC1707, IC1709, IC1710, IC1702, IC1703, IC1711, IC1712, IC1713, IC1714
What the firm is doing
No customer notifications were sent. The retrospectively reported recall does not currently affect any Automated Impella Controllers (AICs) in the field pending the correction. The hardware update was implemented to AICs in the field through servicing to address potential safety concerns.
DistributionShow detailsHide
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.
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2238-2026
- FDA device classification · OZDOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Abiomed, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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