Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDBC3D4 EVERA S IS1/DF4 GLOB, Model Number DDBC3D4; Implantable Cardioverter Defibrillators

Hazard

There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds.

Details from the source

Reason for recall: There is a rare potential for reduced- or no-energy output during high voltage (HV) therapy (typically 0-12J) in implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured with a specific (glassed) feedthrough, including currently available ICDs and CRT-Ds. Distribution: US Nationwide - Worldwide Distribution Quantity: 4056 units Lot/code info: GTIN 00643169720381, Lot Serial Numbers: BWF206541H, BWF206448H, BWF206403H, BWF206382H, BWF206552H, BWF206320H, BWF206323H, BWF206420H, BWF206376H, BWF206458H, BWF206459H, BWF206430H, BWF206453H, BWF206359H, BWF206478H, BWF206333H, BWF206365H, BWF206370H, BWF206557H, BWF206599H, BWF206607H, BWF206551H, BWF206367H, BWF206396H, BWF206421H, BWF206554H, BWF206355H, BWF206461H, BWF206604H, BWF206371H, BWF206373H, BWF206374H, BWF206378H, BWF206380H, BWF206381H, BWF206383H, BWF206387H, BWF206388H, BWF206390H, BWF206449H, BWF206473H, BWF206474H, BWF206475H, BWF206500H, BWF206526H, BWF206527H, BWF206528H, BWF206529H, BWF206535H, BWF206563H, BWF206565H, BWF206567H, BWF206568H, BWF206573H, BWF206574H, BWF206575H, BWF206597H, BWF206598H, BWF206175H, BWF206419H, BWF206327H, BWF206491H, BWF206496H, BWF206401H, BWF206321H, BWF206334H, BWF206338H, BWF206344H, BWF206432H, BWF206470H, BWF206489H, BWF206507H, BWF206558H, BWF206577H, BWF206583H, BWF206570H, BWF206581H, BWF206342H, BWF206410H, BWF206492H, BWF206417H, BWF206424H, BWF206476H, BWF206539H, BWF206580H, BWF206485H, BWF206608H, BWF206601H, BWF206317H, BWF206384H, BWF206395H, BWF206490H, BWF206585H, BWF206590H, BWF206322H, BWF206431H, BWF206443H, BWF206463H, BWF206484H, BWF206487H, BWF206497H, BWF206502H, BWF206505H, BWF206534H, BWF206553H, BWF206569H, BWF206571H, BWF206415H, BWF206451H, BWF206452H, BWF206544H, BWF206546H, BWF206460H, BWF206360H, BWF206440H, BWF206462H, BWF206340H, BWF206435H, BWF206510H, BWF206495H, BWF206375H, BWF2064

UPC codes

00643169720381, 00643169720398, 00643169980235

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.