FDA-Device2021-02-03Class II
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
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.
Sold states
Distribution to US states of GA, PA, NJ, and France
Affected count
2 units
Manufactured in
8200 Coral Sea St Ne, Mounds View, MN, United States
Products
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0928-2021Don't want to check this manually?
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