Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB1QQ VIVA QUAD S IS4/DF4 US, Model Number DTBB1QQ; 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: 193 units Lot/code info: GTIN 00643169720145, Lot Serial Numbers: BLK205268H, BLK205272H, BLK205461H, BLK205544H, BLK205582H, BLK205328H, BLK205358H, BLK205475H, BLK205492H, BLK205304H, BLK205346H, BLK205364H, BLK205269H, BLK205352H, BLK205349H, BLK205400H, BLK205432H, BLK205451H, BLK205309H, BLK205310H, BLK205315H, BLK205514H, BLK205424H, BLK205466H, BLK205513H, BLK205279H, BLK205504H, BLK205314H, BLK205376H, BLK205377H, BLK205394H, BLK205443H, BLK205444H, BLK205275H, BLK205284H, BLK205285H, BLK205287H, BLK205298H, BLK205312H, BLK205379H, BLK205389H, BLK205406H, BLK205415H, BLK205419H, BLK205429H, BLK205431H, BLK205435H, BLK205464H, BLK205471H, BLK205478H, BLK205512H, BLK205517H, BLK205524H, BLK205528H, BLK205541H, BLK205427H, BLK205289H, BLK205387H, BLK205566H, BLK205374H, BLK205508H, BLK205369H, BLK205395H, BLK205311H, BLK205405H, BLK205445H, BLK205472H, BLK205522H, BLK205523H, BLK205531H, BLK205537H, BLK205554H, BLK205450H, BLK205583H, BLK205166H, BLK205286H, BLK205296H, BLK205307H, BLK205329H, BLK205371H, BLK205372H, BLK205458H, BLK205494H, BLK205498H, BLK205570H, BLK205341H, BLK205305H, BLK205317H, BLK205354H, BLK205468H, BLK205469H, BLK205574H, BLK205345H, BLK205363H, BLK205378H, BLK205539H, BLK205534H, BLK205535H, BLK205536H, BLK205295H, BLK205308H, BLK205323H, BLK205335H, BLK205428H, BLK205434H, BLK205440H, BLK205448H, BLK205449H, BLK205489H, BLK205457H, BLK205306H, BLK205276H, BLK205403H, BLK205326H, BLK205330H, BLK205299H, BLK205483H, BLK205565H, BLK205459H, BLK205259H, BLK205292H, BLK2055

UPC codes

00643169720145

Source

Official record: FDA (Device enforcement) ↗

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