Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT… — Class II medical device recall Z-0290-2022
Ongoing recall by Medtronic Vascular, Inc., reported 2021-12-01, distributed nationwide. During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
| Recall number | Z-0290-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Vascular, Inc., Santa Rosa, CA, United States |
| Recall initiated | 2021-10-15 |
| Classified | 2021-11-24 |
| Reported by FDA | 2021-12-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CH, CN, CY, CZ, DE, DK, ES, FI, FR, GB, HU, IE, IT, JO, JP, LT, LU, NL, NO, PL, PT, QA, SE, ZA |
| Quantity | 2 devices |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00763000006129 |
| Serial numbers | V30624638, V30624639 |
Product
Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
Reason for recall
During stent graft deployment, the spindle may detach from the distal end of the spindle hypotube
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-0290-2022. 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.