BEUDAMED
    FDA Recall Open, Classified

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    Recall: Z-0936-2021 · Initiated December 2, 2020

    Recall

    Recall Number
    Z-0936-2021
    Event Number
    86866
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 2, 2020
    Address
    4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700

    Description

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    Reason

    Accelerated battery depletion may result in a need for device replacement earlier than expected.

    Action

    The firm issued an Important Medical Device Advisory beginning on 12/02/2020 to its field representatives and implanting surgeons by letter; The notice explained the issue and provided recommendations for the surgeons and referred the surgeons with additional questions, or to report a clinical event, to their Boston Scientific representative or Technical Services. Patients were also notified of the issue and provided them with the website and instructions on how to confirm whether his/her implant was part of the affected groups.

    Distribution

    worldwide

    Quantity

    11296 units