Impella CP with SmartAssist — Class I medical device recall Z-2319-2024
Ongoing recall by Abiomed, Inc., reported 2024-07-24, distributed in FL, MA, OH, TX. Nine (9) Impella CP pumps failed inspection and were inadvertently released.
| Recall number | Z-2319-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2024-05-31 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | FL, MA, OH, TX |
| Quantity | 9 units |
| UPC / GTIN / UDI-DI | 00813502012279 |
| Lot numbers | 1798046 |
| Serial numbers | 1798046, 504354, 504355, 504356, 504357, 504359, 504360, 504361, 504362, 504363 |
| Model numbers | 0048-0003 |
Product
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Reason for recall
Nine (9) Impella CP pumps failed inspection and were inadvertently released.
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-2319-2024. 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.