Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBC2Q1 BRAVA QUAD IS4/DF1 INTL, Model Number DTBC2Q1; 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: 1754 units Lot/code info: GTIN 00643169720244, Lot Serial Numbers: BLY602416S, BLY602685S, BLY602482S, BLY602743S, BLY602431S, BLY602548S, BLY602563S, BLY602693S, BLY602474S, BLY602424S, BLY602465S, BLY602812S, BLY602676S, BLY602445S, BLY602572S, BLY602497S, BLY602549S, BLY602715S, BLY602735S, BLY602531S, BLY602657S, BLY603005S, BLY602489S, BLY602628S, BLY602652S, BLY602459S, BLY602483S, BLY602576S, BLY602450S, BLY602521S, BLY602574S, BLY602680S, BLY602386S, BLY602463S, BLY602694S, BLY602747S, BLY602449S, BLY602401S, BLY602413S, BLY602432S, BLY602631S, BLY602633S, BLY602672S, BLY602740S, BLY602741S, BLY602403S, BLY602412S, BLY602517S, BLY602528S, BLY602430S, BLY602501S, BLY602270S, BLY602552S, BLY602713S, BLY602478S, BLY602543S, BLY602443S, BLY602464S, BLY602634S, BLY602421S, BLY602564S, BLY602462S, BLY602525S, BLY602673S, BLY602717S, BLY602734S, BLY602467S, BLY602487S, BLY602377S, BLY602682S, BLY602712S, BLY602423S, BLY602659S, BLY602725S, BLY602393S, BLY602524S, BLY602565S, BLY602630S, BLY602378S, BLY602696S, BLY602438S, BLY602475S, BLY602653S, BLY602711S, BLY602661S, BLY602539S, BLY602533S, BLY602558S, BLY602561S, BLY602675S, BLY602534S, BLY602499S, BLY602814S, BLY602368S, BLY602437S, BLY602727S, BLY602435S, BLY602444S, BLY602530S, BLY602688S, BLY602470S, BLY602658S, BLY602453S, BLY602454S, BLY602507S, BLY602555S, BLY602405S, BLY602729S, BLY602477S, BLY602258S, BLY602473S, BLY602720S, BLY602815S, BLY602829S, BLY602833S, BLY602835S, BLY602839S, BLY603060S, BLY602508S, BLY602371S, BLY602388S, BLY6027

UPC codes

00643169720244, 00643169980198, 00763000612337

Source

Official record: FDA (Device enforcement) ↗

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