BEUDAMED
    FDA Enforcement Class I Terminated

    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

    Recall: Z-0879-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0879-2021
    Event ID
    87014
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 27, 2021
    Initiation Date
    November 13, 2020
    Classification Date
    January 19, 2021
    Termination Date
    July 23, 2024
    Address
    4100 Hamline Ave N Bldg 3, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

    Reason

    There is potential for fractures which results in the inability to delivery therapy.

    Code Info

    All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

    Distribution

    Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

    Quantity

    47000 units