Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87769
Description: Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies.
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) Recall 87769 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1650-2021 |
| Event ID | 87769 |
| Event Description | Cobalt HF Quad MRI SureScan Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D) - Product Usage: are multiprogrammable cardiac devices that monitor and regulate a patient s heart rate by providing single- or dual chamber rate responsive bradycardia pacing, cardioversion, and defibrillation therapies. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of North Carolina. |
| Quantity | 2 units |
| Recall Reason | The device may contain a manufacturing defect of a missing resistance spot weld (RSW). |
| Device Classification | 20210526 |
| Device Code Info | Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S |
| Center Classification Date | 20210520 |
| Recall Initiation Date | 20210407 |
| Recalling Firm | Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF) |
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