FDA Labels Inspire Medical's Sleep Apnea Nerve Stimulator Recall As Most Serious

The FDA has labeled a recall of Inspire Medical Systems, Inc.’s INSP nerve-stimulating implant for obstructive sleep apnea as Class I, the most serious kind.

Inspire initiated a recall of its IV Implantable Pulse Generator (IPG) on June 17. The recall extends to 32 devices of the Model 3028 IPG.

Inspire Medical Systems is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect.

The defect can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy. 

The use of the affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in – loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation, or perceived shocking sensation and death. 

There have been no reported injuries. There have been no reports of death. 

The Implantable Pulse Generator is a key component of the Inspire Upper Airway Stimulation system.

The IPG 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 IPG works with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy’s activation and intensity.

Inspire Medical advised affected customers to verify the therapy’s effectiveness by thoroughly assessing signals and resistance.

They recommend regular checkups to detect device-related issues and urge patients to schedule routine office visits with their healthcare providers.

Price Action: INSP shares are down 2.16% at $133.03 at the last check on Tuesday.

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