Recall Z-1098-2026
Medtronic Inc · initiated December 4, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
Beginning 04-Dec-2025, Medtronic distributed an Urgent Medical Device Recall notice to all U.S. consignees who have impacted products via mail courier. Consignees were instructed to complete and return a response form to the firm and to return any affected product they may have.
Details
- Recall number
- Z-1098-2026
- Initiated
- December 4, 2025
- Posted by FDA
- January 15, 2026
- Product code
- QAN – Stent, Iliac Vein
- Quantity
- 442
- 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.
- Recalling firm
- Medtronic Inc, Plymouth, MN