BEUDAMED
    FDA Recall Terminated

    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing.

    Recall: Z-0116-2017 · Initiated October 10, 2016

    Recall

    Recall Number
    Z-0116-2017
    Event Number
    75393
    Firm
    St Jude Medical Inc.
    FEI Number
    2017865
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 10, 2016
    Posted
    October 21, 2016
    Terminated
    September 27, 2018
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Unify, Model No. CD3231-40, CD3231-40Q. Unify Quadra, Model No. CD3249-40, CD3249-40Q. Unify Assura, Model No. CD3257-40, CD3357-40C, CD3357-40Q. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing.

    Reason

    St Jude Medical is recalling implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices because they are subject to premature battery depletion due to lithium cluster with the battery causing a short circuit.

    Action

    St. Jude Medical, Inc., sent a customer letter to all affected customers to inform them that St. Jude Medical recently announced a global medical device advisory for a subset of their company's Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices. The letter informs customers that the cause for Premature Battery Depletion is attributed to the formation of lithium clusters within the battery causing a short circuit. There is a possibility that affected devices may lose battery power within days. Thus far, there have been two (2) deaths and ten (10) serious events (fainting) that may have been associated with premature battery depletion. Customers with questions were instructed to contact www.sjm.com/batteryadvisory, (866) 915-5065.

    Distribution

    Worldwide Distribution - US (nationwide) and OUS

    Quantity

    204,785 units