BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-1098-2026 · Initiated December 4, 2025

    Recall

    Recall Number
    Z-1098-2026
    Event Number
    98157
    Firm
    Medtronic Inc
    FEI Number
    2183870
    Product Code
    QAN
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 4, 2025
    Posted
    January 15, 2026
    Address
    4600 Nathan Ln N, Plymouth, MN, 55442-2890

    Description

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

    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.

    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.

    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 Emirates, United Kingdom, Uzbekistan, Vietnam.

    Quantity

    442