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Inspire Medical Systems removes Inspire IV implantable pulse generator

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

Device use
The Implantable Pulse Generator (IPG) is a key component of the Inspire Upper Airway Stimulation (UAS) 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 together 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. U.S. Food and Drug Administration

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