OPTIMIZER CCM X11 Implantable Pulse Generator May Fail to Deliver Therapy
The OPTIMIZER model CCM X11 implantable pulse generator may incorrectly detect a charging error and cease delivering cardiac therapy, potentially causing patients to experience heart failure symptoms. A total of 1,469 units are affected.
- Product
- OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
- Category
- Medical Device
- Distribution
- Distributed nationwide