Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090
FDA device recall Z-1098-2026 · posted 2026-01-15 · Open, Classified
Recall details
- Recalling firm
- Medtronic Inc
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- QAN
- Quantity affected
- 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, Netherland
- Date initiated
- 2025-12-04
- Date posted
- 2026-01-15
- Location
- Plymouth, MN
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