medical Class II Updated 2022-08-03

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Cobalt Implantable Cardioverter Defibrillators with Cardiac

Recalled Product

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)


Hazard / Issue

Manufacturing error that may have resulted in a cathode component being out of specification. All devices met final functional testing requirements.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: GTIN 00763000178178, Serial Numbers: RTK601865S, RTK601825S, RTK601828S
View official government recall

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