Automated Impella Controller — Class I medical device recall Z-2568-2025
Ongoing recall by Abiomed, Inc., reported 2025-10-01, distributed in AR, AZ, CA, CO, CT, FL, GA, ID…. Specific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current spe
| Recall number | Z-2568-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2025-08-20 |
| Classified | 2025-09-19 |
| Reported by FDA | 2025-10-01 |
| Distributed | AR, AZ, CA, CO, CT, FL, GA, ID, MA, MI, MO, MS, NJ, NY, OH, PA, TX |
| Countries outside the US | CA, DE, IT, NL, NO |
| Quantity | 71 units |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502011272, 00813502011289, 00813502011296 |
| Serial numbers | IC1026, IC1029, IC1040, IC1043, IC1046, IC1047, IC1088, IC1089, IC1093, IC1110, IC1167, IC1221, IC1222, IC1225, IC1250, IC1258, IC1272, IC1281, IC1293, IC1317, IC1320, IC1350, IC1353, IC1354, IC1355 and 46 more |
Product
Automated Impella Controller (AIC) with the below brands and product codes. Used with heart assist pump. 1. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 2. Impella Controller, Packaged, US, Loaner; Product Code: 0042-0000-US-L. 3. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 4. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 5. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 6. Impella Controller, UK, Loaner; Product Code: 0042-0000-UK-L.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2568-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.