Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR)
Reported: February 3, 2021 Initiated: November 15, 2020 #Z-0928-2021
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.
Details
- Recalling Firm
- Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
- Units Affected
- 2 units
- Distribution
- Distribution to US states of GA, PA, NJ, and France
- Location
- Mounds View, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR). Recalled by Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF). Units affected: 2 units.
Why was this product recalled? ▼
Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 3, 2021. Severity: Moderate. Recall number: Z-0928-2021.
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