BEUDAMED
    FDA Enforcement Class II Ongoing

    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

    Recall: Z-0226-2025 · Reported October 30, 2024

    Enforcement

    Recall Number
    Z-0226-2025
    Event ID
    95441
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    October 30, 2024
    Initiation Date
    September 6, 2024
    Classification Date
    October 24, 2024
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific myLUX Patient Application for an Apple Mobile device, Model Number 2939, Version 2.0.101, 2.0.110, cardiac monitor application.

    Reason

    Patients using the Model 2939 myLUX Patient Application on their Apple mobile device (e.g., iPhone) may not be transmitting data from their Insertable Cardiac Monitor to the LATITUDE Clarity website.

    Code Info

    GTIN 00802526618215, Versions 2.0.101, 2.0.110

    Distribution

    Nationwide distribution to AL, AZ, CA, CO, FL, GA, ID, KY, MA, MD, NC, NJ, NY, OH, Puerto Rico, SC, UT, VA, WA.

    Quantity

    7,649 apps