BEUDAMED
    FDA Recall Open, Classified

    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

    Recall: Z-1043-2026 · Initiated December 3, 2025

    Recall

    Recall Number
    Z-1043-2026
    Event Number
    98097
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    December 3, 2025
    Posted
    January 9, 2026
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

    Reason

    Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

    Action

    On December 3, 2025 the firm distributed Urgent Medical Device Safety Notification letters to affected consignees. Customers were instructed to download and install A81200 CP App v2.0.2684 or any later version.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    7123