The FDA labeled a recall of Inspire Medical Systems (NYSE:INSP) implantable pulse generators (IPGs) Class I, the most serious kind.
Inspire initiated a recall of its IV IPG on June 17. The recall involves removing certain devices from where they are used or sold. It extends to 32 devices of the Model 3028 IPG. To date, the company reports zero instances of injury or death related to this recall.
The company, which makes implantable neuromodulation systems for treating sleep apnea, developed its IPG to store therapy settings configured by a physician. It delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles. This maintains airway patency during sleep. Inspire’s IPG works with external programmers to allow physicians to set and adjust therapy parameters for patients.
Inspire Medical recalled the Model 3028 due to a manufacturing defect, according to an FDA notice. 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.
While the company reports no adverse effects to date, using the affected product can lead to adverse health consequences. Those include stimulation below normal therapeutic levels and/or early depletion of battery, resulting in a loss of therapy. Patients may also experience inappropriate or inconsistent stimulation, painful stimulation or perceived shocking sensation and death.
Inspire Medical told affected customers to check if the therapy works by properly analyzing signals and resistance. The company suggests regular checkups to potentially spot issues with the device. Patients should contact their healthcare providers as soon as possible to schedule a routine office visit.
