BEUDAMED
    FDA Recall Open, Classified

    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.

    Recall: Z-1123-2022 · Initiated March 30, 2022

    Recall

    Recall Number
    Z-1123-2022
    Event Number
    89971
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 30, 2022
    Posted
    May 23, 2022
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Vanta INS Implantable Neurostimulator. Medtronic Model 977006 Vanta with AdaptiveStim Technology Neurostimulator with Surescan MRI technology, part of a neurostimulator system for pain therapy.

    Reason

    The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

    Action

    A customer letter, dated March 2022, was issued to the impacted consignee via mail. The consignee is instructed to ensure the patient programmer system is paired with the patient's INS. If the INS cannot communicate with the clinician programmer and/or patient programmer system, and it is not possible to make therapy adjustments, the consignee is to contact Medtronic Technical Services. The consignee is also asked to complete the customer confirmation form and submit to the recalling firm. Medtronic will be notifying consignees and actively retrieving any unused Vanta INS devices that contain the previous firmware version (as of 03-December-2025). Consignees will be asked to sign and return a confirmation form if applicable by region.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, ND, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and the countries of Italy, Sweden, Netherlands, Belgium, United Kingdom, Japan, Finland, Portugal, Spain, Canary Islands, Denmark, Germany, Switzerland, Ireland, Croatia, Norway.

    Quantity

    1021 devices