Recall Z-0928-2021— Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II · Terminated
Class II FDA medical device recall by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF), initiated 2020-11-15, terminated 2025-12-23. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR). Reason: Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function..
- Recalling firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-11-15
- Terminated
- 2025-12-23
- Firm location
- Mounds View, MN, United States
Product description
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Reason for recall
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Data sourced from openFDA. This site is unofficial and independent of the FDA.