Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA1D1 VIVA XT IS1/DF1 US, Model Number DTBA1D1; 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: 1473 units Lot/code info: GTIN 00643169720312, Lot Serial Numbers: BLF258142H, BLF257918H, BLF258186H, BLF258209H, BLF257508H, BLF258084H, BLF257081H, BLF257089H, BLF257260H, BLF257290H, BLF257410H, BLF257440H, BLF257565H, BLF257668H, BLF257684H, BLF257873H, BLF257966H, BLF256897H, BLF257648H, BLF256756H, BLF256776H, BLF256865H, BLF257835H, BLF257086H, BLF257198H, BLF257413H, BLF257605H, BLF257611H, BLF257863H, BLF257960H, BLF257342H, BLF257460H, BLF257657H, BLF256948H, BLF257877H, BLF256848H, BLF257404H, BLF257931H, BLF257961H, BLF258043H, BLF258080H, BLF257904H, BLF257104H, BLF257029H, BLF257408H, BLF257431H, BLF257388H, BLF257618H, BLF257916H, BLF257972H, BLF256843H, BLF256844H, BLF256971H, BLF257125H, BLF257347H, BLF258090H, BLF257677H, BLF258051H, BLF257844H, BLF257627H, BLF257348H, BLF258261H, BLF257215H, BLF257468H, BLF256758H, BLF257803H, BLF258143H, BLF257449H, BLF257885H, BLF257899H, BLF257956H, BLF258078H, BLF258093H, BLF258094H, BLF258178H, BLF258228H, BLF257037H, BLF257384H, BLF258292H, BLF257430H, BLF257459H, BLF256911H, BLF256979H, BLF256984H, BLF256999H, BLF257398H, BLF257568H, BLF257682H, BLF258129H, BLF258141H, BLF258202H, BLF258219H, BLF258236H, BLF258294H, BLF256867H, BLF257276H, BLF258268H, BLF256968H, BLF256969H, BLF257429H, BLF257843H, BLF257437H, BLF257532H, BLF257054H, BLF257651H, BLF256785H, BLF256799H, BLF257456H, BLF258254H, BLF256780H, BLF257014H, BLF258185H, BLF256985H, BLF257147H, BLF257832H, BLF257606H, BLF257866H, BLF256874H, BLF256883H, BLF257230H, BLF257253H, BLF2576

UPC codes

00643169720312, 00763000059545

Source

Official record: FDA (Device enforcement) ↗

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