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IMPULSE DYNAMICS (USA) INC
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for IMPULSE DYNAMICS (USA) INC and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-02-28FDA-DeviceClass IIOPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and Lite
OPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This may cause patients to experience heart failure symptoms similar to before implantation of the device.
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