Automated Impella Controller — Class II medical device recall Z-0441-2024
Terminated recall by Abiomed, Inc., reported 2023-12-13, distributed in AZ, CA, FL, NY, VA. Pump not detected as connected to controller due to software issue.
| Recall number | Z-0441-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-10-10 |
| Classified | 2023-12-01 |
| Reported by FDA | 2023-12-13 |
| Terminated | 2025-03-06 |
| Distributed | AZ, CA, FL, NY, VA |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00813502011401 |
| Serial numbers | IC8386, IC8391, IC8617 |
Product
Automated Impella Controller (AIC), product number 0042-040-US with software versions V8.4 and V8.4.1.
Reason for recall
Pump not detected as connected to controller due to software issue.
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-0441-2024. 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.