FDA-Device2016-11-02Class I
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 card
St Jude Medical Inc.
Hazard
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.
Sold states
Worldwide Distribution - US (nationwide) and OUS
Affected count
204,785 units
Manufactured in
15900 Valley View Ct, Sylmar, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2017Don't want to check this manually?
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