FDA Medical devices recall · June 3, 2026

Automated Impella Controller (AIC) with the below product descriptions and… recall

This is an FDA Class I recall — the most serious type.

Recall number: Z-2238-2026
Date: June 3, 2026 (initiated January 17, 2011)
Company / brand: Abiomed, Inc.
22 Cherry Hill Dr, Danvers, MA, United States
Category: Medical devices › Class I
Classification: Class I
Status: Ongoing
Units affected: 625 units
Initiated by: Voluntary: Firm initiated

Product

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.

Why was it recalled?

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 should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

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,

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.

What does Class I mean?

Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.

Source: FDA (medical devices), recall Z-2238-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.