BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

    Recall: Z-2076-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2076-2021
    Event ID
    88089
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    May 14, 2021
    Classification Date
    July 14, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391, United States

    Description

    Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx Only

    Reason

    Device fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset.

    Code Info

    Model Number: LNQ22

    Distribution

    Worldwide distribution - US Nationwide in the states of AK, AL, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY. The countries of Australia, Austria, Canada, Denmark, Finland, Germany, Ireland, Italy, Netherlands, Netherlands Antilles, Sweden, Switzerland, and United Kingdom.

    Quantity

    21,685