BEUDAMED
    FDA Enforcement Class II 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 · Reported March 25, 2020

    Enforcement

    Recall Number
    Z-1512-2020
    Event ID
    85077
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 25, 2020
    Initiation Date
    February 12, 2020
    Classification Date
    March 18, 2020
    Termination Date
    April 14, 2023
    Address
    4100 Hamline Ave N Bldg 3, Saint Paul, MN, 55112-5700, United States

    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.

    Code Info

    Serial Number 516959

    Distribution

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

    Quantity

    1 device