BEUDAMED
    FDA Recall 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 · Initiated June 29, 2017

    Recall

    Recall Number
    Z-3038-2017
    Event Number
    77803
    Firm
    Boston Scientific Corporation
    FEI Number
    2124215
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    June 29, 2017
    Posted
    August 16, 2017
    Terminated
    February 21, 2019
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    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.

    Action

    The firm issued notifications dated June, 2017, beginning 6/29/2017 to physicians (implanting and patient follow-up physicians) via hand delivery by their sales representatives. The firm estimated approximately 30% of the U.S. physicians would be receiving the notification via hand delivery. Hand delivery by affiliates in foreign countries to customers began approximately 6/30/2017. Overnight mail letters were issued to the U.S. and foreign physicians starting on/about 7/7/2017 who did not receive hand- delivered notifications.

    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