Device product
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.
Z-1650-2021
Product summary
- Event
- Event 87769
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-1650-2021
Official wording
Reason: The device may contain a manufacturing defect of a missing resistance spot weld (RSW).
Code information: Product Number: DTPB2D4, UDI: 00763000178215 Serial Numbers: RTO601595S and RTO601624S
Distribution pattern: US Nationwide distribution in the state of North Carolina.
Derived failure modes
-
Manufacturing or process control
manufacturing defect