BEUDAMED
    FDA Enforcement Class II Ongoing

    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

    Recall: Z-0151-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0151-2023
    Event ID
    90985
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    November 9, 2022
    Initiation Date
    September 30, 2022
    Classification Date
    October 31, 2022
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    EMBLEM S-ICD, Subcutaneous Implantable Defibrillators, Model A209, sterile.

    Reason

    There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.

    Code Info

    UPN: 00802526548406; Serial numbers 169276, 169509, 169645, 169774, 169876, 169671, 169297.

    Distribution

    Worldwide distribution - US Nationwide distribution in the countries of AL, AR, CA, CO, DE, GA, IL, IA, MA, MI, MN, NV, NJ, NY, OH, PA, TN, TX, and VA. The countries of Canada, France, Germany, Latvia, Netherlands, Poland, Sweden, Switzerland, and United Kingdom.

    Quantity

    7 devices