Minnesota-based Inspire Medical Systems is voluntarily recalling a model of its Inspire IV Implantable Pulse Generator because of a manufacturing defect, the FDA said July 8.
After implantation, the generators might malfunction and cause electrical leakage in the sensing circuit.
The device "stores therapy settings configured by a physician and delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles, to maintain airway patency during sleep," the agency said.
Using the affected product could cause painful stimulation or require patients to undergo revision surgery. Zero injuries or deaths have been reported.