Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBA1D4 VIVA XT IS1/DF4 US, Model Number DTBA1D4; 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: 661 units Lot/code info: GTIN 00643169720251, Lot Serial Numbers: BLE221424H, BLE221443H, BLE221244H, BLE221357H, BLE221415H, BLE221487H, BLE221190H, BLE221267H, BLE221842H, BLE221265H, BLE221430H, BLE221711H, BLE221346H, BLE221631H, BLE221285H, BLE221405H, BLE221436H, BLE221551H, BLE221411H, BLE221342H, BLE221584H, BLE221694H, BLE221282H, BLE221465H, BLE221191H, BLE221384H, BLE221805H, BLE221309H, BLE221222H, BLE221327H, BLE221548H, BLE221562H, BLE221702H, BLE221450H, BLE221715H, BLE221246H, BLE221654H, BLE221686H, BLE221713H, BLE221750H, BLE221758H, BLE221814H, BLE221828H, BLE221843H, BLE221844H, BLE221851H, BLE221854H, BLE221855H, BLE221861H, BLE221561H, BLE221727H, BLE221751H, BLE221789H, BLE221862H, BLE221670H, BLE221707H, BLE221752H, BLE221849H, BLE221475H, BLE221687H, BLE221601H, BLE221748H, BLE221173H, BLE221336H, BLE221413H, BLE221426H, BLE221580H, BLE221174H, BLE221176H, BLE221759H, BLE221227H, BLE221660H, BLE221334H, BLE221627H, BLE220376H, BLE221338H, BLE221213H, BLE221349H, BLE221658H, BLE221661H, BLE221348H, BLE221378H, BLE221423H, BLE221680H, BLE221808H, BLE221542H, BLE221633H, BLE221819H, BLE221863H, BLE221292H, BLE221368H, BLE221492H, BLE221608H, BLE221269H, BLE221700H, BLE221418H, BLE221251H, BLE221761H, BLE221242H, BLE221472H, BLE221473H, BLE221718H, BLE221444H, BLE221662H, BLE221723H, BLE221738H, BLE221746H, BLE221778H, BLE221343H, BLE221823H, BLE221830H, BLE221180H, BLE221262H, BLE221324H, BLE221495H, BLE221505H, BLE221509H, BLE221615H, BLE221622H, BLE221705H, BLE221279H, BLE2212

UPC codes

00643169720251, 00763000059668

Source

Official record: FDA (Device enforcement) ↗

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