Medtronic Inc recalls Abre Venous Self-Expanding Stent System
- Recalling company
- Medtronic Inc
- Product
- Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Dec 4, 2025
- Reported
- Jan 21, 2026
- Distribution
- Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebanon, Malaysia, Netherlands, New Zealand, Peru, Poland, Russia, Singapore, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uzbekistan, Vietnam.
- Status
- Ongoing
- Quantity
- 442
- Lot / codes
- UDI-DI (GTIN): 00763000547332 00763000547271 00763000547318 00763000547264 00643169796225 00643169796300 00643169796294 00643169796232 00643169796287 00763000547325 00643169796300 00763000547257 Serial/Lot numbers C112511 C113253 C113795 C117416 C117482 C121084 C123953 C133327 C133329 C134478 C138060 C150325
- Company location
- Plymouth, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1098-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1098-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.