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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resyn
Recalled February 3, 2021 · FDA recall Z-0927-2021 · Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Hazard
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. · FDA Class II
Units
2 units
Sold at
Distribution to US states of GA, PA, NJ, and France
Description
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
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)
Manufacturer(s)
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →