Abre Venous Self-expanding Stent System — Class II medical device recall Z-1317-2024
Ongoing recall by Medtronic Inc., reported 2024-03-27, distributed nationwide. There is a potential for sterile package breach.
| Recall number | Z-1317-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc., Plymouth, MN, United States |
| Recall initiated | 2024-02-16 |
| Classified | 2024-03-19 |
| Reported by FDA | 2024-03-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, CH, CO, DE, ES, FI, GB, NL, PT |
| Quantity | 65 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00643169796294, 00643169796409, 00763000547325 |
| Lot numbers | B456626, B456811, B460542 |
Product
Abre Venous Self-expanding Stent System, Product Numbers: a) AB9U14080090; b) AB9U18100090; c) AB9G14100090
Reason for recall
There is a potential for sterile package breach.
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-1317-2024. 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.