BEUDAMED
    FDA Recall Completed

    LINQ II Insertable Cardiac Monitor

    Recall: Z-0782-2022 · Initiated January 18, 2022

    Recall

    Recall Number
    Z-0782-2022
    Event Number
    89469
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    MXD
    Status
    Completed
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 18, 2022
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    LINQ II Insertable Cardiac Monitor

    Reason

    Devices may lose functionality due to susceptibility to moisture ingress.

    Action

    On or around January 18, 2002, in the United States, Medtronic will begin notifying notified customers of the field corrective action and patient management recommendations via 2-day UPS delivery. Consignees were provided with proper patient management recommendations. Consignees are asked to complete and return a confirmation certification confirming they have received the notification. Outside the United States (OUS), communication will begin no later than 18-JAN-2022 using locally approved methods.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of NJ, NY, PA, and VA. The country of Italy.

    Quantity

    8 devices