Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 86887
Description: 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) Recall 86887 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0928-2021 |
| Event ID | 86887 |
| Event Description | Medtronic Cobalt DR MRI SureScan DDPB3D1, MR Conditional implantable dual chamber cardioverter defibrillator with SureScan technology and Bluetooth wireless telemetry (DDE-DDDR) |
| Product Type | Devices |
| Distribution | Distribution to US states of GA, PA, NJ, and France |
| Quantity | 2 units |
| Recall Reason | Under rare circumstances, the component may be susceptible to a failure mechanism that could impact device performance, including potential loss of function. |
| Device Classification | 20210203 |
| Device Code Info | Serial Numbers: RSN600251S, RSN600656S |
| Center Classification Date | 20210126 |
| Recall Initiation Date | 20201115 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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