FDA-Device2021-02-03Class II
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)
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 HF CRT-D MRI SureScan DTPB2D1, MR Conditional implantable cardioverter defibrillator with cardiac resynchronization therapy, SureScan technology, and Bluetooth wireless telemetry (DDE-DDDR)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0927-2021Don't want to check this manually?
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