BEUDAMED
    FDA Enforcement Class II Terminated

    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    Recall: Z-1632-2016 · Reported May 18, 2016

    Enforcement

    Recall Number
    Z-1632-2016
    Event ID
    73837
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    St Jude Medical Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2016
    Initiation Date
    March 31, 2016
    Classification Date
    May 9, 2016
    Termination Date
    June 29, 2016
    Address
    15900 Valley View Ct, N/A, Sylmar, CA, 91342-3577, United States

    Description

    Ellipse ICD (Implantable Cardioverter Defibrillator) Model CD2411-36Q, CD2411-36C, CD1411-36Q, CD1411-36C Product Usage: Ellipse ICD devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

    Reason

    St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy.

    Code Info

    Serial No. 7263877 7263892 7263900 7263904 7264199 7265399 7265400 7265401 7263916 7264214 7264398 7265581

    Distribution

    Worldwide Distribution - US Nationwide in the states of CT, NJ, SC, FL, GA and countries of: Finland, France, Germany, Great Britain, Greece, Israel, Italy, Japan, Kuwait, Lebanon, Netherlands, Northern Ireland, Poland, Romania, Slovakia, Spain, Tunis, United Arab Emirates, and Vietnam.

    Quantity

    127 units