Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1
Recalled Product
CRTD DTBA2D1G VIVA XT IS1 DF1 OUS GOLD, Model Number DTBA2D1G; Implantable Cardioverter Defibrillators
Hazard / Issue
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.
Issued by
FDA
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