Impella 5 — Class I medical device recall Z-1590-2023
Ongoing recall by Abiomed, Inc., reported 2023-05-24, distributed nationwide. The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
| Recall number | Z-1590-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2023-04-17 |
| Classified | 2023-05-18 |
| Reported by FDA | 2023-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CH, DE, ES, FR, GB, HR, IT, JP, KW, NO, RS, SA, SI |
| Quantity | 610 units |
| Reason classes | packaging |
| Serial numbers | 313711, 313730, 313762, 313780, 316678, 317849, 319440, 320326, 320332, 320593, 321229, 321271, 321274, 323883, 323887, 323958, 324062, 324151, 324292, 324328, 324340, 324342, 325116, 326264, 326320 and 475 more |
Product
Impella 5.5 with SmartAssist catheter is an intravascular micro axial blood pump that supports a patient s circulatory system, Product Numbers 1000211 (Impella 5.5 JP), 0550-0002 (Impella 5.5 Smart Assist), and 0550-0008 (Impella 5.5 with SmartAssist Set, US)
Reason for recall
The Impella 5.5 pump experienced a heightened complaint rate for purge leaks.
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-1590-2023. 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.