medical Class I Updated 2023-06-28

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

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00763000615611. Lot Serial Numbers: RSL602260S, RSL602263S, RSL602265S
View official government recall

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