Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1
Recalled Product
ICD DDPA2D1G COBALT XT DR MRI DF1 GOLD, Model Number DDPA2D1G; 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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