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
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