ABIOMED Impella CP Smart Assist Set — Class I medical device recall Z-2690-2026
Ongoing recall by Abiomed, Inc., reported 2026-07-22, distributed nationwide. A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified
| Recall number | Z-2690-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abiomed, Inc., Danvers, MA, United States |
| Recall initiated | 2026-06-11 |
| Classified | 2026-07-10 |
| Reported by FDA | 2026-07-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BR, CA, CH, CN, CZ, DE, DK, ES, FI, FR, GB, GR, HK, HR, IE, IL, IT, JP, KR, KW, LU, MX, MY, NL, NO, PA, PL, RS, SA, SE, SI, TH, TW |
| Quantity | 8,382 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00813502011609 |
Product
ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP; containing Introducer Product Code 0052-3025-JP. heart pump and accessories
Reason for recall
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set.
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-2690-2026. 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.