Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBC2D4 BRAVA IS1/DF4 INTL, Model Number DTBC2D4; 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: 3355 units Lot/code info: GTIN 00643169720305, Lot Serial Numbers: BLZ604044S, BLZ604109S, BLZ603698S, BLZ603713S, BLZ603726S, BLZ603835S, BLZ604013S, BLZ604101S, BLZ603725S, BLZ604036S, BLZ604059S, BLZ603770S, BLZ604032S, BLZ603602S, BLZ603626S, BLZ604001S, BLZ603743S, BLZ604536S, BLZ603622S, BLZ604076S, BLZ604915S, BLZ604263S, BLZ603735S, BLZ603422S, BLZ603918S, BLZ604138S, BLZ603587S, BLZ603604S, BLZ603663S, BLZ603723S, BLZ603840S, BLZ604082S, BLZ604065S, BLZ604080S, BLZ604102S, BLZ603740S, BLZ603967S, BLZ604467S, BLZ603620S, BLZ603705S, BLZ603788S, BLZ603812S, BLZ603977S, BLZ603978S, BLZ603980S, BLZ604031S, BLZ604072S, BLZ604134S, BLZ604097S, BLZ603639S, BLZ603941S, BLZ604056S, BLZ603594S, BLZ603683S, BLZ603720S, BLZ603898S, BLZ603921S, BLZ603982S, BLZ603983S, BLZ604057S, BLZ604135S, BLZ604908S, BLZ603732S, BLZ603787S, BLZ604146S, BLZ603643S, BLZ603958S, BLZ604107S, BLZ603796S, BLZ603605S, BLZ603902S, BLZ604049S, BLZ603694S, BLZ604103S, BLZ603716S, BLZ604111S, BLZ604006S, BLZ604110S, BLZ604099S, BLZ603874S, BLZ603894S, BLZ604093S, BLZ603972S, BLZ603859S, BLZ603603S, BLZ603614S, BLZ603856S, BLZ604005S, BLZ603595S, BLZ603813S, BLZ603880S, BLZ603899S, BLZ604014S, BLZ604053S, BLZ604016S, BLZ604017S, BLZ603879S, BLZ604051S, BLZ603615S, BLZ603906S, BLZ604909S, BLZ603861S, BLZ604075S, BLZ604087S, BLZ604139S, BLZ604913S, BLZ603623S, BLZ603913S, BLZ603616S, BLZ603825S, BLZ603612S, BLZ603844S, BLZ603960S, BLZ603795S, BLZ603803S, BLZ603784S, BLZ604069S, BLZ603627S, BLZ603642S, BLZ603752S, BLZ603834S, BLZ6039

UPC codes

00643169720305, 00643169980136

Source

Official record: FDA (Device enforcement) ↗

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