Abre Venous Self-Expanding Stent System — Class II medical device recall Z-1098-2026
Ongoing recall by Medtronic Inc, reported 2026-01-21, distributed nationwide. Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and correspond
| Recall number | Z-1098-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Inc, Plymouth, MN, United States |
| Recall initiated | 2025-12-04 |
| Classified | 2026-01-15 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, CH, CL, CO, CR, DE, DK, DO, ES, FI, GB, JO, LB, MY, NL, NZ, PE, PL, RU, SG, TH, TW, VN |
| Quantity | 442 |
| UPC / GTIN / UDI-DI | 00643169796225, 00643169796232, 00643169796287, 00643169796294, 00643169796300, 00763000547257, 00763000547264, 00763000547271, 00763000547318, 00763000547325, 00763000547332 |
| Lot numbers | C112511, C113253, C113795, C117416, C117482, C121084, C123953, C133327, C133329, C134478, C138060, C150325 |
| Model numbers | AB9G12060090, AB9G12080090, AB9G12100090, AB9G14080090, AB9G14100090, AB9G14120090, AB9U12060090, AB9U12080090, AB9U14060090, AB9U14080090, AB9U14100090 |
Product
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Reason for recall
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in 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-1098-2026. 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.