BEUDAMED
    FDA Recall Terminated

    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    Recall: Z-1512-2020 · Initiated February 12, 2020

    Recall

    Recall Number
    Z-1512-2020
    Event Number
    85077
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 12, 2020
    Posted
    March 3, 2020
    Terminated
    April 14, 2023
    Address
    4100 Hamline Ave N, Bldg 3, Saint Paul, MN, 55112-5700

    Description

    Boston Scientific, Implantable Cardioverter Defibrillator, DYNAGEN EL ICD DR, Model D152 - Product Usage: Implantable cardioverter defibrillators (ICDs) are intended to provide ventricular anti-tachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    Reason

    Boston Scientific released a new Software Update Application that was downloaded to four (4) distributed Model 3300 programmers. The Software Update Application then directed these programmers to download software applications that have not been approved by the US Food and Drug Administration.

    Action

    The firm initiated the recall by letter on 12/12/2020. The letter explained the error and requested the consignee segregate the units for removal. The firm will provide another model of programmer to be used in the interim.

    Distribution

    US Nationwide distribution in the states of NC, TN, and MO.

    Quantity

    1 device