Abiomed Impella CP Set with SmartAssist — Class I medical device recall Z-2601-2026
Ongoing recall by Abiomed, Inc., reported 2026-07-01, distributed nationwide. Potential for thrombus formation during prolonged use of the introducer.
| Recall number | Z-2601-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-05-22 |
| Classified | 2026-06-25 |
| Reported by FDA | 2026-07-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP |
| Quantity | 168 units |
| UPC / GTIN / UDI-DI | 00813502013566, 00813502013948 |
| Lot numbers | 2026724558, 2026787668, 2027818660, 2027818724 |
| Serial numbers | 649727, 649728, 649729, 649730, 649731, 650264, 653001, 653002, 653003, 653004, 653005, 653006, 653007, 653008, 653009, 653010, 653041, 653042, 653043, 653044, 653045, 653047, 653048, 653049, 653050 and 143 more |
Product
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low Profile Introducer Kits. Product Codes: 1000413, 1000834.
Reason for recall
Potential for thrombus formation during prolonged use of the introducer.
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-2601-2026. 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.