Automated Impella Controller — Class II medical device recall Z-1175-2024
Terminated recall by Abiomed, Inc., reported 2024-02-28, distributed nationwide. Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Availab
| Recall number | Z-1175-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2021-03-01 |
| Classified | 2024-02-22 |
| Reported by FDA | 2024-02-28 |
| Terminated | 2025-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 4,463 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00813502010022, 00813502010985, 00813502011401 |
Product
Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
Reason for recall
Retrospective reporting for the release of Technical Bulletin IMP-2643 AIC Version 8.5 Software Update Available. The update resolved an issue in version 8.4 where a pump was not recognized by the AIC.
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-1175-2024. 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.