BEUDAMED
    FDA Enforcement Class II Ongoing

    Medtronic Reveal LINQ LNQ11 / PA96000

    Recall: Z-2102-2021 · Reported July 28, 2021

    Enforcement

    Recall Number
    Z-2102-2021
    Event ID
    88175
    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 28, 2021
    Initiation Date
    June 1, 2021
    Classification Date
    July 20, 2021
    Address
    8200 Coral Sea St Ne, N/A, Mounds View, MN, 55112-4391, United States

    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.

    Code Info

    All serial numbers distributed on or after February 23, 2017 GTIN: 643169845763, 643169845770, 643169845787, 643169845794, 643169845800, 643169845817, 643169845824, 00643169845831, 00643169845848, 00643169845855, 00643169845862, 00643169845879, 00643169845893, 00763000188382, 00763000188399, 00763000188405, 00763000188412, 00763000188429, 00763000188436, 00763000188443, 00763000188450, 00763000188467, 643169845688, 643169845695, 643169845701, 643169845718, 643169845732, 643169845749, 643169845756

    Distribution

    Worldwide Distribution

    Quantity

    666210 devices