Inspire Sleep Apnea Implant Recall Remains an Ongoing Concern, With Patients Receiving Continued Monitoring

Individuals who received recalled Inspire sleep apnea devices may be approaching their annual checkups, requiring long-term monitoring to detect electrical irregularities with the implant that may signal a defect.

More than a year after Inspire Medical Systems recalled certain sleep apnea implants, due to an electrical defect that could cause painful shocks or inconsistent therapy, the U.S. Food and Drug Administration (FDA) continues to list the action as an open Class I recall, indicating that physicians should keep monitoring affected patients for potential device malfunctions.

Inspire Medical Systems, headquartered in Golden Valley, Minnesota, specializes in minimally invasive treatments for obstructive sleep apnea (OSA), a condition that causes repeated pauses in breathing during sleep. Its Inspire Upper Airway Stimulation (UAS) system was approved by the FDA in 2014, as the first implantable neurostimulation therapy for adults with moderate to severe OSA, who could not tolerate continuous positive airway pressure (CPAP) treatment.

The Inspire system consists of three components: a small implantable pulse generator in the chest, a stimulation lead that activates the hypoglossal nerve to move the tongue forward, and a sensing lead that tracks breathing patterns. Patients turn therapy on before bed using a remote control or smartphone app, eliminating the need for CPAP masks or hoses. This “mask-free” design made Inspire a popular alternative for patients unable to adjust to traditional sleep-apnea machines.

However, as production expanded, a manufacturing issue at a third-party facility in Tennessee prompted an Inspire implant recall last year, impacting the company’s Model 3028 Implantable Pulse Generator, which powers many of the systems already placed inside the bodies of individuals with chronic sleep apnea.

Inspire Sleep Apnea Recall: FDA Class I

Inspire issued an Urgent Medical Device Correction about the problems in June 2024, after identifying a manufacturing defect in its Inspire IV pulse generator that could lead to electrical leakage in the sensing circuit. The problem was discovered in 32 devices worldwide, all part of Model 3028.

The FDA classified the Inspire recall as Class I, its highest risk category, warning that the defect could cause serious complications if undetected. According to the agency, the malfunction may result in:

• Understimulation, leading to loss of airway support during sleep
• Painful or inconsistent electrical shocks
• Premature battery depletion, interrupting therapy
• Complete loss of stimulation, requiring surgical replacement

Each recalled device carries the unique device identifier (UDI) 0855728005915, with specific lot numbers published in the FDA’s recall database. Although the manufacturer has maintained that no injuries or deaths have been reported in connection with the defect, doctors have been encouraged to continue monitoring patients, and the FDA warns that ongoing use of an affected implant may pose a risk of serious injury or death if the malfunction progresses.

Following the discovery, Inspire sent correction letters to implanting surgeons and hospitals instructing them to identify affected patients, verify therapy function, and perform diagnostic testing during upcoming visits. Patients were urged to contact their physicians for evaluation if they experienced symptoms such as fatigue, daytime sleepiness or recurring snoring. The company also created a helpline at 1-844-OSA-HELP (672-4357) to coordinate follow-up appointments and replacement requests.

The affected implants were distributed between August 2022 and May 2023, a period when Inspire’s fourth-generation system was gaining broader clinical use. Inspire has since corrected the manufacturing process, and no additional units are impacted.

Inspire Sleep Apnea Electrical Leakage

According to the FDA, the electrical leakage defect affects the sensing circuit that regulates timing and signal delivery to the hypoglossal nerve. When current escapes the circuit, the implant may misinterpret breathing rhythms or deliver erratic pulses, disrupting the airway stimulation sequence.

These electrical faults can cause painful sensations, loss of therapy or rapid battery drain, sometimes forcing the device to shut down unexpectedly. Because the malfunction can appear intermittently, the FDA advises that waveform and impedance testing is the most reliable way to detect it. Early identification can prevent unnecessary revision surgery and help restore consistent sleep therapy.

While no adverse events have been reported, the agency warns that untreated device failure could contribute to oxygen deprivation, fatigue, or other complications related to persistent sleep apnea.

Ongoing FDA Monitoring and Follow-Up Testing

As of September 2025, the FDA Inspire recall remains active in the agency’s database, and physicians continue to perform enhanced monitoring for patients who may have received an affected device. Many of these patients are now reaching their 18- to 24-month post-implant follow-ups, when device testing is routine, bringing renewed focus to ensuring system reliability.

According to the FDA’s recall instructions, healthcare providers are directed to conduct waveform and impedance testing at every patient visit.

These tests measure how the implant responds at multiple voltage levels to detect electrical irregularities that may signal a defect. Patients are informed that they may feel three short pulses as voltage levels are tested between 1.5 and 3.5 volts, allowing doctors to verify proper function without invasive procedures.

If irregularities appear, clinicians are instructed to contact Inspire’s representatives for additional diagnostics or guidance on replacement surgery. Patients are also encouraged to report any changes in stimulation strength, unexpected sensations, or signs that therapy effectiveness has decreased. Routine non-invasive monitoring, the FDA says, is usually sufficient to detect potential malfunctions before symptoms become severe.

Although the recall involves a limited number of devices, the ongoing surveillance into 2025 demonstrates how the FDA continues to prioritize long-term oversight of implantable medical technology.

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