Inspire Medical Systems Recalls Implantable Pulse Generator

Inspire Medical Systems has issued a recall for the Inspire IV Implantable Pulse Generator (IPG) Model 3028 because of a manufacturing defect that could disrupt therapy and cause serious adverse events, according to a statement from the US Food and Drug Administration (FDA). 

The IPG is part of the Inspire Upper Airway Stimulation system that works to deliver mild electrical stimulation to the hypoglossal nerve and maintain adequate airflow during sleep.

The manufacturing defect can cause electrical leakage in the device’s sensing circuit, according to the statement. The recall involves of the devices from where they are used or sold, and the device may cause death or serious injury if patients continue to use it.

The voluntary recall, issued on June 17, 2024, involves 32 different devices of Model 3028. Healthcare providers should schedule appointments as soon as possible to check the status of these devices in patients who are using them, and continue regular check-ups to analyze signals and resistance that may indicate problems with the device without resorting to surgery, according to the recall. Patients using the devices are advised to schedule an office visit to check for a potential IPG defect and to be vigilant to changes in the device stimulation, lack of effectiveness, or problems turning the device on. Patients also should visit their providers as soon as possible if they experience new or recurring symptoms such as fatigue, sleepiness, and snoring problems.

Potential adverse consequences of the defect include inadequate stimulation, early battery depletion resulting in loss of therapy, inappropriate or inconsistent stimulation effects, painful stimulation, perceived sensation of shocking, and potential death. As of July 12, no injuries or deaths associated with the devices have been reported. 

Some patients may need revision surgery to replace the device and restore therapy, according to the FDA statement.

If a revision surgery is needed to replace the device, clinicians should contact Inspire’s Patient and Physician Services by phone at 1-844-672-4357 for more information. A full list of the impacted devices is available at the end of the FDA statement online.

Clinicians and patients may report any adverse events or other problems with the devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.