Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; Implant
Recalled Product
CRT-D VIVA QUAD XT GOLD CTD, Model Number DTBA2QQG; 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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