Recall Z-0003-2018— 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: Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q; Fortify DR, Model Numbers: CD2231-40 and CD2231-40Q; Fortify ST DR, Model Numbers: CD2241-40 and CD2241-40Q; Fortify Assura DR, Model Numbers: CD2257-40, CD2257-40Q, CD2357-40C, CD2357-40Q; Fortify Assura ST DR, Model Numbers: CD2263-40, CD2263-40Q, CD2363-40C, CD2363-40Q Product Usage 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. 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.