Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional imp
Recalled Product
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with 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
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