Impella CP Set with SmartAssist — Class I medical device recall Z-2457-2026
Ongoing recall by Abiomed, Inc., reported 2026-06-24, distributed in GA, IA, NE, PA, TX, WA, WI. Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some
| Recall number | Z-2457-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-05-18 |
| Classified | 2026-06-18 |
| Reported by FDA | 2026-06-24 |
| Distributed | GA, IA, NE, PA, TX, WA, WI |
| Countries outside the US | CZ, JP, NO |
| Quantity | 10 units |
| UPC / GTIN / UDI-DI | 00813502012279 |
| Serial numbers | 0048-0014, 0048-0024-JP, 1000080, 1000851, 644314, 644591, 645428, 672986, 673252 |
Product
Impella CP Set with SmartAssist. Product Codes: 1000080, 1000851, 0048-0014, 0048-0024-JP.
Reason for recall
Exposure to the low purge pressure occurrence may result in persistent low purge pressure alarms and, in some cases, interruption or loss of mechanical circulatory support.
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-2457-2026. 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.