Inspire IV Implantable Pulse Generator FDA Recalled

Inspire Medical Systems’ Inspire IV Implantable Pulse Generator (IPG) recall recently nabbed FDA class I identification connected to a manufacturing defect.

The IPG — which stores therapy settings configured by a physician and delivers mild electrical stimulation to the hypoglossal nerve, controlling the tongue muscles to maintain airway patency during sleep — is a key component of the Inspire Upper Airway Stimulation (UAS) system. It works together with outside programmers that allow physicians to set and change therapy parameters, as well as letting the patient control therapy activation and intensity.

The model 3028 IPG of the device was initially recalled by the company after it was found that it contained a manufacturing defect which could cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. Use of an affected device may result in the need for revision surgery to replace the IPG and restore therapy.

If used, affected product could cause stimulation below normal therapeutic levels and/or early depletion of battery, inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death.

In response to the reports, Inspire sent all affected customer an Urgent Medical Device Correction Letter on June 17, recommending that healthcare providers notify patients of the recall, check patients to make sure the device is working correctly by analyzing signals and resistance, look out for any changes to stimulation, lack of therapy effectiveness, or problems turning the therapy on. Additionally, the company said to continue regulator check-ups and tests to analyze signals and resistance at every visit because doing so can spot issues without surgery.

Inspire also recommended patients to visit a provider as soon as possible to ensure routine office visits in order to undergo this non-invasive diagnostic monitoring. If new symptoms or reoccurrence of systems occur, including fatigue, perceived sleepiness, snoring problems, contact a physician for a comprehensive evaluation, which may include polysomnography.

Currently, 32 model 3028 IPG devices have been recalled. There have been no reported injuries or deaths connected to the issue.