Impella 5 — Class II medical device recall Z-1030-2026
Ongoing recall by Abiomed, Inc., reported 2026-01-14. Device packaged in incorrect outer box carton.
| Recall number | Z-1030-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2025-12-04 |
| Classified | 2026-01-08 |
| Reported by FDA | 2026-01-14 |
| Countries outside the US | AU, TW |
| Quantity | 6 units |
| UPC / GTIN / UDI-DI | 00813502012828 |
| Serial numbers | 621454, 621455 |
| Model numbers | 1000482 |
| Expiration dates | 2027-06-30 |
Product
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Reason for recall
Device packaged in incorrect outer box carton.
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-1030-2026. 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.