Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB1D4 VIVA S IS1/DF4 US, Model Number DTBB1D4; 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: 182 units Lot/code info: GTIN 00643169720268, Lot Serial Numbers: BLN205385H, BLN205423H, BLN205617H, BLN205500H, BLN205517H, BLN205644H, BLN205573H, BLN205101H, BLN205395H, BLN205424H, BLN205448H, BLN205505H, BLN205574H, BLN205579H, BLN205432H, BLN205460H, BLN205545H, BLN205566H, BLN205554H, BLN205583H, BLN205390H, BLN205669H, BLN205438H, BLN205653H, BLN205533H, BLN205387H, BLN205527H, BLN205528H, BLN205571H, BLN205591H, BLN205623H, BLN205485H, BLN205501H, BLN205594H, BLN205618H, BLN205381H, BLN205462H, BLN205684H, BLN205479H, BLN205509H, BLN205627H, BLN205663H, BLN205682H, BLN205382H, BLN205384H, BLN205549H, BLN205557H, BLN205482H, BLN205454H, BLN205548H, BLN205560H, BLN205408H, BLN205521H, BLN205529H, BLN205552H, BLN205491H, BLN205645H, BLN205586H, BLN205480H, BLN205516H, BLN205486H, BLN205520H, BLN205417H, BLN205415H, BLN205558H, BLN205630H, BLN205655H, BLN205458H, BLN205435H, BLN205428H, BLN205555H, BLN205446H, BLN205420H, BLN205481H, BLN205399H, BLN205437H, BLN205459H, BLN205463H, BLN205476H, BLN205477H, BLN205518H, BLN205565H, BLN205575H, BLN205577H, BLN205611H, BLN205624H, BLN205457H, BLN205506H, BLN205643H, BLN205648H, BLN205652H, BLN205434H, BLN205456H, BLN205441H, BLN205507H, BLN205592H, BLN205650H, BLN205596H, BLN205570H, BLN205513H, BLN205413H, BLN205508H, BLN205584H, BLN205660H, BLN205674H, BLN205677H, BLN205536H, BLN205576H, BLN205610H, BLN205659H, BLN205539H, BLN205386H, BLN205499H, BLN205393H, BLN205495H, BLN205466H, BLN205502H, BLN205542H, BLN205439H, BLN205613H, BLN205561H, BLN2054

UPC codes

00643169720268

Source

Official record: FDA (Device enforcement) ↗

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