Abiomed REF: 0052-3006 — Class I medical device recall Z-2680-2026
Ongoing recall by Oscor Inc., reported 2026-07-22. Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the si
| Recall number | Z-2680-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Oscor Inc., Palm Harbor, FL, United States |
| Recall initiated | 2026-06-10 |
| Classified | 2026-07-10 |
| Reported by FDA | 2026-07-22 |
| Quantity | 32,934 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 00813502011609, 00885672009755 |
| Model numbers | 0052-3006 |
Product
Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion Sideport, 23F. heart pump and accessories.
Reason for recall
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region.
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-2680-2026. 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.