—#217744

Product

Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090

FDA product code: QAN — Stent, Iliac Vein
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P200026
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc
Address: 4600 Nathan Ln N, Plymouth, Minnesota 55442-2890

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2025-12-04
Posted by FDA: 2026-01-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217744. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.