Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDBB1D1 EVERA XT IS1/DF1 US, Model Number DDBB1D1; 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: 2179 units Lot/code info: GTIN 00643169720404, Lot Serial Numbers: BWC242988H, BWC241999H, BWC242338H, BWC242392H, BWC243112H, BWC243417H, BWC243633H, BWC243786H, BWC244004H, BWC241880H, BWC242816H, BWC243834H, BWC241861H, BWC242999H, BWC241742H, BWC241891H, BWC241930H, BWC242022H, BWC242027H, BWC242157H, BWC242236H, BWC242463H, BWC242464H, BWC242466H, BWC242482H, BWC242567H, BWC242583H, BWC242645H, BWC242697H, BWC242718H, BWC242721H, BWC242804H, BWC242997H, BWC243009H, BWC243043H, BWC243095H, BWC243211H, BWC243216H, BWC243245H, BWC243258H, BWC243378H, BWC243488H, BWC243489H, BWC243590H, BWC243657H, BWC243711H, BWC243743H, BWC243863H, BWC244033H, BWC244161H, BWC244282H, BWC244431H, BWC242166H, BWC242897H, BWC243484H, BWC243570H, BWC244218H, BWC244438H, BWC241690H, BWC242739H, BWC243166H, BWC243372H, BWC243918H, BWC241761H, BWC243769H, BWC241692H, BWC242218H, BWC242258H, BWC242430H, BWC242496H, BWC242627H, BWC243113H, BWC243183H, BWC243398H, BWC243422H, BWC243536H, BWC243559H, BWC244411H, BWC244490H, BWC242381H, BWC243436H, BWC244026H, BWC243607H, BWC241926H, BWC241948H, BWC241974H, BWC242093H, BWC242228H, BWC242252H, BWC242403H, BWC242418H, BWC242691H, BWC242815H, BWC243736H, BWC244061H, BWC244445H, BWC243128H, BWC243679H, BWC243790H, BWC244388H, BWC244448H, BWC242617H, BWC242853H, BWC243562H, BWC241824H, BWC242272H, BWC243100H, BWC243698H, BWC241903H, BWC242624H, BWC242224H, BWC242479H, BWC242772H, BWC243108H, BWC243202H, BWC243246H, BWC243535H, BWC243578H, BWC244175H, BWC243274H, BWC244352H, BWC2430

UPC codes

00643169720404, 00763000059569

Source

Official record: FDA (Device enforcement) ↗

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