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Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) recalls Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureSc
Recalled February 3, 2021 · FDA recall Z-0928-2021 · 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 DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with 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 →