Impella 2 — Class I medical device recall Z-2111-2023
Ongoing recall by Abiomed, Inc., reported 2023-07-26, distributed nationwide. There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of
| Recall number | Z-2111-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-06-14 |
| Classified | 2023-07-14 |
| Reported by FDA | 2023-07-26 |
| Distributed | Nationwide (US) |
| Quantity | 9,252 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813502011081 |
Product
Impella 2.5 intravascular micro axial blood pump, Product Number 005042
Reason for recall
There is a potential risk for unintentional interaction of the Impella motor housing with the distal stent of a transcatheter aortic valve replacement (TAVR) resulting in destruction of the impeller blades. This has resulted in low flow from the damaged Impella system. Systemic embolization of the fractured impeller material is a possibility.
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-2111-2023. 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.