BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

    Recall: Z-0295-2022 · Reported December 1, 2021

    Enforcement

    Recall Number
    Z-0295-2022
    Event ID
    88953
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Neuromodulation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 1, 2021
    Initiation Date
    November 4, 2021
    Classification Date
    November 24, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568, United States

    Description

    Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

    Reason

    The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

    Code Info

    UDI 00763000217921

    Distribution

    US Nationwide, including PR. There was government distribution but no military distribution was identified.

    Quantity

    10 devices