Reported Oct 1, 2025 · Ongoing
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 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?
6 of 6 products
| Model / number | Product as published |
|---|---|
0042-0000-US. | Impella Controller, Packaged, US |
0042-0000-US-L. | Impella Controller, Packaged, US, Loaner |
0042-0000-CA. | Impella Controller, Packaged, CA |
0042-0000-EU. | Impella Controller, Packaged, EU |
0042-0000-UK. | Impella Controller, Packaged, UK |
0042-0000-UK-L. | Impella Controller, UK, Loaner |
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Product as published 813502010022Product Code: 0042-0000-US; ; Serial Numbers: IC1026, IC1029, IC1043, IC1046, IC1040, IC1047, IC1088, IC1089, IC1093, IC1110, IC1167, IC1221, IC1225, IC1222, IC1258, IC1250, IC1272, IC1293, IC1320, IC1317, IC1353, IC1354, IC1355, IC1375, IC1377, IC1403, IC1446, IC1450, IC1452, IC1461, IC1496, IC1501, IC1508, IC1515, IC1516, IC1517, IC1518, IC1530, IC1534, IC1535, IC1539, IC1538, IC1531, IC1533, IC1540, IC1532, IC1551, IC1552, IC1550, IC1553, IC1646, IC1756, IC2255, IC2422, IC2489, IC3013. 813502010022Product Code: 0042-0000-US-L; ; Serial Number: IC1281. 813502011272Product Code: 0042-0000-CA; ; Serial Numbers: IC1543, IC1544. 813502011289Product Code: 0042-0000-EU; ; Serial Numbers: IC1350, IC1383, IC1546, IC1548, IC1547, IC1549, IC1775, IC2243, IC4002. 813502011296Product Code: 0042-0000-UK; ; Serial Numbers: IC1519, IC1542. 813502011296Product Code: 0042-0000-UK-L; ; Serial Number: IC1493. - Amount recalled
- 71 units
Where it was sold
Why it was recalled
Stop using this product now
Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased pump performance or pump stop and trigger an Impella Failure or Impella Stopped Controller Failure alarm.
Using this product could cause serious injury, illness or death — stop using it now.
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