Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF): CRT-D DTBB1D1 VIVA S IS1/DF1 US, Model Number DTBB1D1; 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: 207 units Lot/code info: GTIN 00643169720329, Lot Serial Numbers: BLO214422H, BLO214561H, BLO214374H, BLO214534H, BLO214440H, BLO214546H, BLO214564H, BLO214574H, BLO214347H, BLO214424H, BLO214577H, BLO214311H, BLO214464H, BLO214492H, BLO214410H, BLO214276H, BLO214283H, BLO214290H, BLO214368H, BLO214376H, BLO214395H, BLO214448H, BLO214539H, BLO214405H, BLO214499H, BLO214390H, BLO214496H, BLO214548H, BLO214344H, BLO214362H, BLO214352H, BLO214253H, BLO214274H, BLO214288H, BLO214342H, BLO214444H, BLO214327H, BLO214333H, BLO214431H, BLO214473H, BLO214273H, BLO214317H, BLO214418H, BLO214445H, BLO213867H, BLO214272H, BLO214289H, BLO214316H, BLO214526H, BLO214261H, BLO214279H, BLO214287H, BLO214296H, BLO214297H, BLO214301H, BLO214302H, BLO214303H, BLO214436H, BLO214535H, BLO214536H, BLO214543H, BLO214549H, BLO214550H, BLO214551H, BLO214552H, BLO214553H, BLO214571H, BLO214579H, BLO214581H, BLO214582H, BLO214584H, BLO214585H, BLO214586H, BLO214335H, BLO214308H, BLO214379H, BLO214348H, BLO214366H, BLO214312H, BLO214353H, BLO214530H, BLO214568H, BLO214260H, BLO214334H, BLO214413H, BLO214430H, BLO214437H, BLO214441H, BLO214475H, BLO214570H, BLO214397H, BLO214321H, BLO214394H, BLO214538H, BLO214269H, BLO214271H, BLO214282H, BLO214315H, BLO214343H, BLO214365H, BLO214383H, BLO214391H, BLO214417H, BLO214423H, BLO214446H, BLO214463H, BLO214501H, BLO214513H, BLO214532H, BLO214547H, BLO214559H, BLO214563H, BLO214565H, BLO213863H, BLO214567H, BLO214291H, BLO214295H, BLO214322H, BLO214351H, BLO214358H, BLO214369H, BLO2144

UPC codes

00643169720329

Source

Official record: FDA (Device enforcement) ↗

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