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Inspire Medical Announces Major Implantable Pulse Generator Recall

The FDA has announced a recall of Inspire Medical Systems’ (NYSE:INSP) Class I, or most serious, implantable pulse generators (IPGs).

Inspire began recalling its IV IPG on June 17. The recall involves removing some devices from locations where they are used or sold. It involves 32 Model 3028 IPG devices. The company has not reported any injuries or deaths related to the recall.

The company, which makes implantable neuromodulation systems for treating sleep apnea, designed its IPG to store therapy settings configured by a doctor. It delivers mild electrical stimulation to the hypoglossal nerve, which controls the tongue muscles. This keeps the airway open during sleep. Inspire’s IPG works with third-party developers to allow doctors to set and customize therapy parameters for patients.

Inspire Medical has recalled the Model 3028 due to a manufacturing defect, according to the FDA. The defect can cause system failures after implantation, leading to current leakage in the sensor circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy.

Although the company has not reported any adverse effects to date, use of the affected product could lead to adverse health effects. These include stimulation below normal therapeutic levels and/or premature battery depletion, resulting in loss of therapy. Patients may also experience inappropriate or inconsistent stimulation, painful stimulation, or perceived shock and death.

Inspire Medical has advised affected customers to check whether the therapy is working by properly analyzing the signals and resistance. The company suggests regular checkups to potentially detect issues with the device. Patients should contact their healthcare providers as soon as possible to schedule a routine office visit.