Impella RP Flex with SmartAssist — Class I medical device recall Z-1470-2026
Ongoing recall by Abiomed, Inc., reported 2026-03-11, distributed nationwide. Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
| Recall number | Z-1470-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-01-27 |
| Classified | 2026-02-27 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, CH, CZ, DE, FR, HK, HR, IT, PL, RS |
| Quantity | 4,496 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813502012811 |
Product
Impella RP Flex with SmartAssist. Product Code: 1000323.
Reason for recall
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
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-1470-2026. 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.