Recall Z-1098-2026 ยท QAN Stent, Iliac Vein
Medtronic Inc
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G12060090
| Date | Jan 15, 2026 (initiated Dec 4, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.