Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBC2QQ BRAVA QUAD IS4/DF4 INTL, Model Number DTBC2QQ; 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: 7994 units Lot/code info: GTIN 00643169720183, Lot Serial Numbers: BLX611513S, BLX610983S, BLX610727S, BLX609800S, BLX610700S, BLX611193S, BLX611227S, BLX610459S, BLX613336S, BLX611231S, BLX610972S, BLX610821S, BLX611566S, BLX611238S, BLX610596S, BLX610449S, BLX610925S, BLX611306S, BLX610523S, BLX611147S, BLX611439S, BLX610568S, BLX611464S, BLX611546S, BLX611733S, BLX611813S, BLX612082S, BLX612083S, BLX612440S, BLX611069S, BLX611190S, BLX611293S, BLX610441S, BLX611452S, BLX610586S, BLX610739S, BLX611422S, BLX610467S, BLX610671S, BLX611002S, BLX611400S, BLX611499S, BLX611540S, BLX611542S, BLX611554S, BLX611561S, BLX611732S, BLX610299S, BLX611218S, BLX611398S, BLX611547S, BLX611549S, BLX611565S, BLX611613S, BLX610991S, BLX611110S, BLX611987S, BLX610490S, BLX611737S, BLX610446S, BLX610447S, BLX611511S, BLX611605S, BLX610480S, BLX611940S, BLX611927S, BLX610329S, BLX610451S, BLX610464S, BLX610989S, BLX611220S, BLX611515S, BLX611564S, BLX611611S, BLX611742S, BLX611923S, BLX610854S, BLX611391S, BLX611392S, BLX611931S, BLX611943S, BLX610340S, BLX611357S, BLX610393S, BLX610614S, BLX610931S, BLX610937S, BLX610978S, BLX611312S, BLX611366S, BLX611739S, BLX611962S, BLX611982S, BLX610624S, BLX611988S, BLX610470S, BLX611616S, BLX611201S, BLX611688S, BLX610744S, BLX610607S, BLX611683S, BLX611111S, BLX610476S, BLX610789S, BLX611524S, BLX610289S, BLX610484S, BLX610509S, BLX611370S, BLX611626S, BLX610516S, BLX611740S, BLX610392S, BLX611991S, BLX610386S, BLX610522S, BLX610678S, BLX610987S, BLX611390S, BLX610285S, BLX6103

UPC codes

00643169720183, 00643169980167

Source

Official record: FDA (Device enforcement) ↗

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