Reported Jun 3, 2026 · Ongoing
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella…
Abiomed, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abiomed, Inc. · 22 Cherry Hill Dr · Danvers, MA · 01923-2575
Is this the product you have?
4 of 4 products
| Model / number | Product as published |
|---|---|
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-US. | Impella Controller, Packaged, US |
- Lot codes and dates
- 1
- Product Code0042-0000-CA
- GTIN00813502011272
- Serial Numbers
IC1324IC1346IC1480IC1481IC1543IC1544IC1572IC1595IC1598IC1664IC1665IC1715. 2
- Product Code0042-0000-EU
- GTIN00813502011289
- Serial Numbers
IC1217IC1265IC1275IC1276IC1288IC1284IC1301IC1302IC1304IC1305IC1344IC1341IC1343IC1340IC1345IC1350IC1347IC1349IC1383IC1381IC1384IC1386IC1393IC1396IC1397IC1395IC1413IC1415IC1411IC1416IC1490IC1488IC1522IC1523IC1524IC1525IC1547IC1549IC1546IC1548IC1578IC1577IC1579IC1580IC1594IC1584IC1590IC1592IC1591IC1585IC1588IC1653IC1676IC1685IC1684IC1677IC1678IC1699IC1700. 3
- Product Code0042-0000-UK
- GTIN00813502011296
- Serial Numbers
IC1387IC1389IC1388IC1519IC1542IC1545IC1581IC1582IC1583IC1573. 4
- Product Code0042-0000-US
- GTIN00813502010022
- Serial Numbers
544 of 544 codes
IC1004IC1002IC1001IC1006IC1007IC1008IC1014IC1015IC1017IC1019IC1024IC1025IC1028IC1029IC1026IC1027IC1033IC1035IC1031IC1032IC1036IC1037IC1038IC1039IC1041IC1042IC1044IC1049IC1043IC1046IC1053IC1055IC1052IC1040IC1030IC1056IC1047IC1051IC1050IC1060IC1061IC1062IC1064IC1065IC1066IC1067IC1074IC1070IC1071IC1072IC1073IC1068IC1069IC1058IC1075IC1076IC1077IC1078IC1079IC1084
- Amount recalled
- 625 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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