Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 3, 2026

Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA

Full official 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.

Verification delayed

The last verified facts remain visible. Last successful verification: Jul 31, 2026, 12:43 AM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

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.

Identifiers to compare

  • Serial Numbers
Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 00...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, IC1714.625 unitsZ-2238-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

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.

Agency classification: Class I

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

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.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

No material affected-item, risk, action, or status change has been recorded since this page entered the tracker.