Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): ICD-DR DDBC3D1 EVERA S IS1/DF1 GLOB, Model Number DDBC3D1; 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: 5176 units Lot/code info: GTIN 00643169720411, Lot Serial Numbers: BWG208720H, BWG208284H, BWG208405H, BWG208608H, BWG208700H, BWG208763H, BWG208301H, BWG208376H, BWG208406H, BWG208412H, BWG208520H, BWG208539H, BWG208652H, BWG208716H, BWG208296H, BWG208340H, BWG208484H, BWG208220H, BWG208234H, BWG208641H, BWG208702H, BWG208758H, BWG208430H, BWG208206H, BWG208215H, BWG208561H, BWG208216H, BWG208705H, BWG208502H, BWG208221H, BWG208236H, BWG208488H, BWG208403H, BWG208312H, BWG208557H, BWG208335H, BWG208530H, BWG208634H, BWG208745H, BWG208746H, BWG208249H, BWG208654H, BWG208291H, BWG208515H, BWG208596H, BWG208636H, BWG208637H, BWG208730H, BWG208757H, BWG208213H, BWG208347H, BWG208597H, BWG208605H, BWG208692H, BWG208514H, BWG208640H, BWG208326H, BWG208499H, BWG208223H, BWG208491H, BWG208541H, BWG208573H, BWG208304H, BWG208323H, BWG208345H, BWG208370H, BWG208672H, BWG208250H, BWG208270H, BWG208346H, BWG208389H, BWG208482H, BWG208494H, BWG208495H, BWG208497H, BWG208498H, BWG208521H, BWG208547H, BWG208396H, BWG208799H, BWG208224H, BWG208225H, BWG208258H, BWG208261H, BWG208272H, BWG208275H, BWG208276H, BWG208279H, BWG208328H, BWG208337H, BWG208343H, BWG208357H, BWG208360H, BWG208361H, BWG208416H, BWG208417H, BWG208422H, BWG208423H, BWG208462H, BWG208464H, BWG208465H, BWG208468H, BWG208469H, BWG208470H, BWG208471H, BWG208472H, BWG208581H, BWG208583H, BWG208584H, BWG208585H, BWG208586H, BWG208587H, BWG208588H, BWG208639H, BWG208647H, BWG208649H, BWG208660H, BWG208661H, BWG208663H, BWG208664H, BWG208668H, BWG2086

UPC codes

00643169720411, 00643169720428, 00643169980228

Source

Official record: FDA (Device enforcement) ↗

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