Recall Z-0004-2018— St Jude Medical Inc.

Class I FDA medical device recall by St Jude Medical Inc., initiated 2017-08-28, terminated 2024-01-20. FDA's recall record names no specific 510(k) clearance for this event. Product: Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model Numbers: CD3269-40, CD3269-40Q, CD3369-40C, CD3369-40Q 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: The device may exhibit premature battery depletion..

Recalling firm

St Jude Medical Inc.

Classification

Class I

Status

Terminated

Initiated

2017-08-28

Terminated

2024-01-20

Firm location

Sylmar, CA, United States

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