Zenith Alpha Abdominal Endovascular Graft — Class II medical device recall Z-2546-2020
Terminated recall by Cook Inc., reported 2020-07-15. Identified products may contain a damaged bushing within the delivery system, which could potentially result i
| Recall number | Z-2546-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2020-06-02 |
| Classified | 2020-07-09 |
| Reported by FDA | 2020-07-15 |
| Terminated | 2022-05-05 |
| Countries outside the US | AR, AT, AU, BE, CA, CL, CO, CZ, DE, DK, FR, GB, GR, HK, HU, IE, IL, IS, NO, PL, PT, RS, SE, TH, ZA |
| Quantity | 571 |
Product
Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
Reason for recall
Identified products may contain a damaged bushing within the delivery system, which could potentially result in difficulty or an inability to fully deploy the graft via the standard method provided in the IFU.
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-2546-2020. 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.