Impella RP Flex with SmartAssist intracardiac microaxial blood pump — Class I medical device recall Z-2281-2023
Ongoing recall by Abiomed, Inc., reported 2023-08-09, distributed nationwide. A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus fo
| Recall number | Z-2281-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-06-29 |
| Classified | 2023-08-03 |
| Reported by FDA | 2023-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 166 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00813502012811 |
| Serial numbers | 409541, 409542, 409544, 411379, 416645, 416646, 416647, 416649, 418933, 418939, 418940, 419489, 421953, 421955, 422974, 422978, 423999, 425596, 428726, 428730, 429616, 429617, 429623, 429646, 429648 and 40 more |
Product
Impella RP Flex with SmartAssist intracardiac microaxial blood pump, Product Number 1000323
Reason for recall
A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis
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-2281-2023. 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.