BEUDAMED
    FDA Recall Open, Classified

    Medtronic Reveal LINQ LNQ11 / PA96000

    Recall: Z-2102-2021 · Initiated June 1, 2021

    Recall

    Recall Number
    Z-2102-2021
    Event Number
    88175
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    MXD
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 1, 2021
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Medtronic Reveal LINQ LNQ11 / PA96000

    Reason

    Reveal LINQ with TruRhythm ICMs, that undergo a partial electrical reset appear to be programmed "ON", but are no longer able to detect and report Brady and Pause events to clinicians.

    Action

    The firm began notifying their consignees on 06/02/2021 by letter. The letter explained the issue, provided patient management recommendations, and reported that a software update was anticipated in late 2021. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-929-4043.

    Distribution

    Worldwide Distribution

    Quantity

    666210 devices