medical Class II Updated 2021-02-03

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Condition

Recalled Product

Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)


Hazard / Issue

Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.

Issued by

FDA

Affected States: GA, PA, NJ
Lot/Code Info: Serial Numbers: RTP601047S, RTP601055S
View official government recall

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