Recall Z-0116-2017— St Jude Medical Inc.

Class I FDA medical device recall by St Jude Medical Inc., initiated 2016-10-10, terminated 2018-09-27. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..

Recalling firm

St Jude Medical Inc.

Classification

Class I

Status

Terminated

Initiated

2016-10-10

Terminated

2018-09-27

Firm location

Sylmar, CA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.