Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-VR DVFB1D4 VISIA MRI AF US DF4, Model Number DVFB1D4; 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: 34350 units Lot/code info: GTIN 00643169720794, Lot Serial Numbers: PKX219646H, PKX220040H, PKX220056H, PKX221681H, PKX222407H, PKX222934H, PKX223422H, PKX225541H, PKX228394H, PKX228784H, PKX228814H, PKX230405H, PKX231486H, PKX232877H, PKX233043H, PKX236253H, PKX238847H, PKX238969H, PKX224741H, PKX224742H, PKX226542H, PKX230306H, PKX231799H, PKX231802H, PKX234882H, PKX234889H, PKX236705H, PKX236715H, PKX239415H, PKX240693H, PKX234754H, PKX237931H, PKX221151H, PKX222802H, PKX224257H, PKX227009H, PKX227059H, PKX227453H, PKX229189H, PKX231976H, PKX232346H, PKX233404H, PKX235182H, PKX236627H, PKX240315H, PKX219199H, PKX221009H, PKX221252H, PKX221253H, PKX221256H, PKX221257H, PKX221262H, PKX221264H, PKX221271H, PKX221272H, PKX221273H, PKX221276H, PKX224585H, PKX224586H, PKX224589H, PKX224590H, PKX224592H, PKX224593H, PKX224594H, PKX224595H, PKX229231H, PKX229232H, PKX229234H, PKX229237H, PKX229239H, PKX229240H, PKX230943H, PKX230945H, PKX230956H, PKX230960H, PKX230961H, PKX230962H, PKX230965H, PKX230967H, PKX234196H, PKX234197H, PKX234214H, PKX234215H, PKX234216H, PKX234217H, PKX234220H, PKX234221H, PKX236947H, PKX237017H, PKX237021H, PKX237022H, PKX237023H, PKX237024H, PKX237037H, PKX237040H, PKX237043H, PKX237044H, PKX237045H, PKX237046H, PKX237048H, PKX237049H, PKX237051H, PKX237052H, PKX237054H, PKX237055H, PKX237056H, PKX239045H, PKX239046H, PKX239050H, PKX239053H, PKX239056H, PKX239057H, PKX239063H, PKX239064H, PKX239065H, PKX239066H, PKX239067H, PKX239068H, PKX239069H, PKX218877H, PKX221372H, PKX2214

UPC codes

00643169720794

Source

Official record: FDA (Device enforcement) ↗

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