FDA Class I · Medical device · Recall Z-2238-2026 · Recalled June 3, 2026
Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc. Compare identifiers Agency action Open official record ↗ Agency report date: June 3, 2026.
Source checks: October 22, 2026 at 6:00 PM UTC (oldest successful check).
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1. Compare your item This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
Product named Automated Impella Controller (AIC) with the below product descriptions and corresponding P Company / brand Abiomed Lot / serial / date codes 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. Distribution 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. Agency product description and boundaries 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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
2. Agency hazard and consumer action FDA reports: 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.
No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.
Class I: most serious — reasonable probability of serious health consequences or death.
Affected product: Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall status
3. Open the official notice or contact View the official FDA enforcement record (openFDA) ↗
Official recall ID Z-2238-2026 Brand All Abiomed recalls Classification Class I Units affected 625 units Recall status Ongoing Initiated Voluntary: Firm initiated Affected products Companies & origin Recalling firm location Danvers, MA, United States Firm address 22 Cherry Hill Dr, 01923-2575 Identifying details (verbatim from the notice) Product codes / lots 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. Distribution 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. Firm notified the public via Other FDA event ID 98868 Recall initiated January 17, 2011 FDA classified May 28, 2026 FDA report date June 3, 2026 More Abiomed recalls Impella Optical Controller recall — Abiomed, Inc. FDA · September 23, 2026 Impella Optical Controller with the below product descriptions and corresponding Product C recall — Abiomed, Inc. FDA · September 23, 2026 Automated Impella Controller (AIC) with the below product descriptions and corresponding P recall — Abiomed, Inc. FDA · September 23, 2026 ABIOMED Intro Kit recall — Abiomed, Inc. FDA · July 22, 2026 ABIOMED Insertion Kit recall — Abiomed, Inc. FDA · July 22, 2026 Other medical device recalls from around the same time Atlan A350XL recall — Draeger, Inc. FDA · June 10, 2026 Atlan A350 recall — Draeger, Inc. FDA · June 10, 2026 Medline kits containing Huons Co recall — Medline Industries, LP FDA · June 3, 2026 Medline kits containing Huons Co recall — Medline Industries, LP FDA · June 3, 2026 Medline kits containing Huons Co recall — Medline Industries, LP FDA · June 3, 2026
Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes;
the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved September 1, 2026 at 6:00 PM UTC.
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