BEUDAMED
    FDA Enforcement Class II Ongoing

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    Recall: Z-2048-2026 · Reported May 13, 2026

    Enforcement

    Recall Number
    Z-2048-2026
    Event ID
    98679
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 13, 2026
    Initiation Date
    March 30, 2026
    Classification Date
    May 1, 2026
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700, United States

    Description

    LUX-DX II, Arrythmia detector and alarm, Model M302, with SERVER SW LATITUDE DRAGON US, Model 6460, Version 7.5

    Reason

    For some patients upgraded from a LUX-Dx M301 device to a new Model M302 or M312, the new ICM device is not collecting PVC Burden data (both M302/M312) or monitoring for Bradyarrhythmia and Pause (M312 only). In addition, for these devices that are not being monitored, the LATITUDE Clarity programming screens have discrepant information, indicating that the monitoring is enabled for these features in one location and not enabled in another location.

    Code Info

    LUX-DX II UDI-DI: 00802526620713; SERVER SW LATITUDE DRAGON US UDI-DI: SERVER SW LATITUDE DRAGON US; Serial Number: 104263 109787

    Distribution

    Worldwide distribution - US Nationwide and the country of Belgium.

    Quantity

    2 units