Automated Impella Controller (AIC) with the below product descriptions and corresponding Product ...
FDA Device Recall #Z-2238-2026 — Class I — January 17, 2011
Recall Summary
| Recall Number | Z-2238-2026 |
| Classification | Class I — Serious risk |
| Date Initiated | January 17, 2011 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Abiomed, Inc. |
| Location | Danvers, MA |
| Product Type | Devices |
| Quantity | 625 units |
Product Description
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.
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.
Distribution Pattern
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.
Lot / Code Information
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, 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.
Other Recalls from Abiomed, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2211-2026 | Class I | Automated Impella Controller (AIC); Product Co... | Apr 20, 2026 |
| Z-1589-2026 | Class I | Purge Cassette, sold within Impella Pump Sets a... | Feb 18, 2026 |
| Z-1591-2026 | Class I | Automated Impella Controller (AIC), labeled as ... | Feb 16, 2026 |
| Z-1470-2026 | Class I | Impella RP Flex with SmartAssist. Product Code:... | Jan 27, 2026 |
| Z-1471-2026 | Class I | Impella RP. Product Code: 0046-0011. | Jan 27, 2026 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.