Instructions for Use for all model numbers of the Medtronic Abre… — Class II medical device recall Z-0464-2022
Terminated recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), reported 2022-01-12, distributed nationwide. There have been reports of stent migration.
| Recall number | Z-0464-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), Mounds View, MN, United States |
| Recall initiated | 2021-11-19 |
| Classified | 2022-01-06 |
| Reported by FDA | 2022-01-12 |
| Terminated | 2024-08-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, CH, CL, CO, CR, CZ, DE, DK, EG, ES, FI, FR, GB, GR, GT, HK, HR, IE, IL, IN, IT, JO, KE, LT, MY, NI, NL, NO, NZ, OM, PE, PL, PT, SA, SE, SG, TR, TW, UA, UY, VN, ZA |
| Quantity | 21,653 devices |
Product
Instructions for Use for all model numbers of the Medtronic Abre Venous Self-Expanding Stent System.
Reason for recall
There have been reports of stent migration.
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-0464-2022. 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.