BEUDAMED
    FDA Enforcement Class II Terminated

    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing

    Recall: Z-3038-2017 · Reported August 23, 2017

    Enforcement

    Recall Number
    Z-3038-2017
    Event ID
    77803
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    August 23, 2017
    Initiation Date
    June 29, 2017
    Classification Date
    August 15, 2017
    Termination Date
    February 21, 2019
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    EMBLEM MRI S-ICD Model 219, Subcutaneous-Implantable Cardioverter Defibrillator, Rx. Product Usage: The S-ICD system is intended to provide defibrillation therapy for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not have symptomatic bradycardia, incessant ventricular tachycardia, or spontaneous, frequently recurring ventricular tachycardia that is reliably terminated with anti-tachycardia pacing

    Reason

    The device can deliver an atypical amount of energy due to memory corruption inside the device.

    Code Info

    All serial numbers

    Distribution

    Worldwide - US Nationwide distribution, including Puerto Rico, U.S. Virgin Island, and Guam, There was also worldwide foreign distribution, including Canada.

    Quantity

    Approximately 9,200 devices