Medtronic Inc: Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 A
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medtronic Inc
- Product
- Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
- Reason / hazard
- 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
- Status
- Ongoing
- Distribution / sold at
- 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.
- Recall initiated
- 2025-12-04
- 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
- Product quantity
- 442
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Plymouth
- State
- MN
- Country
- United States
- Event id
- 98157
Free daily digest + "My products" watchlist