BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported January 21, 2026

    Enforcement

    Recall Number
    Z-1043-2026
    Event ID
    98097
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 21, 2026
    Initiation Date
    December 3, 2025
    Classification Date
    January 9, 2026
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    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.

    Code Info

    version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

    Distribution

    Worldwide - US Nationwide distribution.

    Quantity

    7123