FDA DevicesClass II
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G1210009...
Published: January 21, 2026Recall ID: Z-1098-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Affected Products
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
Additional Source Details
| Field | Value |
|---|---|
| City | Plymouth |
| State | MN |
| Event id | 98157 |
| Address 1 | 4600 Nathan Ln N |
| 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 |
| Postal code | 55442-2890 |
| Report date | 20260121 |
| Product type | Devices |
| Product quantity | 442 |
| 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20251204 |
| Initial firm notification | Letter |
| Center classification date | 20260115 |
Overview
- Recalling FirmMedtronic Inc
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide - 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.