FDA amplifies Inspire Medical's sleep apnea nerve stimulator recall

The FDA has elevated a recall of Inspire Medical’s nerve-stimulating implant for the treatment of obstructive sleep apnea.

The agency handed down a Class I recall designation to the effort, its most serious label, due to a manufacturing defect that could result in what it described as “electrical leakage”—where malfunctions could result in abnormally fast battery drains, weakened therapy delivery or potential shocks. The FDA said no patient injuries or deaths have been reported.

The company first began recalling its Inspire IV implantable pulse generator June 17, with letters to healthcare providers and patients asking them to schedule a routine checkup.

According to Inspire, a noninvasive diagnostic process is capable of identifying those with the defect, however, a revision surgery procedure may be necessary to replace the hardware. The FDA said as many as 32 devices could be affected.

The small implant is placed near the collarbone during a minimally invasive, outpatient procedure; it is designed to sense breathing patterns and stimulate the hypoglossal nerves that help control the muscles of the tongue in order to keep the airway open during sleep.

In June 2023, the FDA issued a new approval that expanded the implant’s label, allowing it to be used in a broader number of patients. That green light was also highlighted in the agency’s annual report on novel medical devices. The system first launched in 2014 as a second-line therapy for moderate to severe obstructive sleep apnea.

During its most recent quarterly earnings report in May, Inspire said about 1,250 medical centers in the U.S. were now providing its therapy. 

The company logged $164 million in revenue for the first quarter, up 28% from the year before, as well as $154.5 million in operating expenses as it builds up its sales force, direct-to-patient marketing programs and R&D efforts. Inspire projected an increase of about 26% in its full-year revenue for 2024, landing somewhere between $783 million and $793 million.