The Inspire sleep apnea lawsuits fall into four separate tracks: a product liability case from a Louisiana patient who says his implant delivered hours of uncontrolled shocks, a securities fraud class action from investors over the troubled launch of the Inspire V device, a U.S. Department of Justice civil investigation into the company’s billing and marketing, and a patent fight with competitor Nyxoah. A Class I FDA recall of a small batch of older Inspire IV pulse generators sits alongside these cases. An earlier investor suit from 2023, over a different set of allegations, was dismissed with prejudice in March 2025.
The Patient Product Liability Case
In February 2026, Blake and Heidi Luquette sued Inspire Medical Systems in Louisiana state court. The case was removed to the U.S. District Court for the Western District of Louisiana in April 2026 (No. 6:2026cv01139). 1Justia. Luquette v. Inspire Medical Systems Docket
According to the complaint, Blake Luquette received an Inspire implant in December 2023. On or about February 25, 2025, the device allegedly delivered “repeated, uncontrolled electrical shocks for several hours.” Surgeons removed the device on April 4, 2025. 2AboutLawsuits. Inspire Sleep Apnea Lawsuit: Hours of Electrical Shocks
The Luquettes allege the device was defectively designed and inadequately tested, and that Inspire failed to warn about the risk of uncontrolled electrical stimulation. Their claims sound in negligence, product liability, and failure to warn, and they seek damages for physical and mental suffering, lost earnings, permanent disability, and disfigurement. 2AboutLawsuits. Inspire Sleep Apnea Lawsuit: Hours of Electrical Shocks
Inspire withdrew an initial motion to dismiss after the plaintiffs filed an amended complaint. The company’s answer was due by June 12, 2026. 1Justia. Luquette v. Inspire Medical Systems Docket The case is the only patient product liability suit against Inspire disclosed in the public record so far. It has not been consolidated with any other action, and there is no multidistrict litigation covering Inspire devices.
The Class I Recall of Inspire IV Pulse Generators
In May 2024, Inspire initiated a recall of the Inspire IV implantable pulse generator (Model 3028) after identifying a manufacturing defect that could cause electrical leakage in the sensing circuit. The defect risked abnormally fast battery drain, weakened therapy delivery, or potential shocks. 3Fierce Biotech. FDA Amplifies Inspire Medical’s Sleep Apnea Nerve Stimulator Recall The FDA later designated the action a Class I recall, its most serious category.
The recall was narrow. It covered 24 devices distributed in the United States and three in Europe. 4FDA. Recall – Inspire Model 3028 IV Implantable Pulse Generator No injuries or deaths were reported in connection with the recall. 3Fierce Biotech. FDA Amplifies Inspire Medical’s Sleep Apnea Nerve Stimulator Recall Noninvasive diagnostics can identify the defect, but affected patients may require revision surgery to replace the device. If you have an Inspire IV implant, your implanting physician can confirm whether your device is within the affected serial number range.
Known Complications and Adverse Events
A review of the FDA’s MAUDE adverse event database covering reports through May 2020 identified 180 reports containing 196 adverse events tied to Inspire devices. Infection was the most common, accounting for about 34% of reports, followed by nerve injury and bleeding or fluid accumulation. More than 42% of reported adverse events required a second surgery, most commonly to remove the device entirely. 5ScienceDirect. Adverse Events Associated With Hypoglossal Nerve Stimulation
Clinical trial data from the STAR study showed that up to 40% of participants experienced some form of adverse event, including discomfort and nerve irritation. 5ScienceDirect. Adverse Events Associated With Hypoglossal Nerve Stimulation Inspire’s own safety disclosures list risks including pain, swelling, temporary tongue weakness, infection, discomfort from stimulation, tongue abrasion, and, in rare cases, tongue weakness and atrophy. 6Inspire Medical Systems. Safety Information
The Investor Lawsuit Over the Inspire V Launch
On August 4, 2025, Inspire disclosed that the commercial rollout of its next-generation Inspire V device was going far worse than expected. The company slashed its full-year 2025 adjusted earnings-per-share guidance from $2.20–$2.30 down to 40–50 cents, a reduction of more than 80%. 7MassDevice. Inspire Medical Faces Investor Class Action
The company cited several problems: treatment centers had not completed the training and onboarding required to implant the new device, the cloud-based SleepSync patient management system that accompanies Inspire V proved difficult for hospitals’ IT departments to install, Medicare reimbursement software updates tied to the new CPT code did not take effect until July 1, 2025, and providers still held surplus inventory of the older Inspire IV. 8BLB&G. Indiana Public Retirement System v. Inspire Medical Systems Complaint9Sleep Review. Why Inspire V Slower Than Expected Adoption
Shares fell from $129.95 to $87.91 by the close on August 5, 2025, a drop of more than 32% in a single session. From the class period high of $216.71 in September 2024, the total decline was nearly 60%. 10GlobeNewsWire. INSP Stockholders With Large Losses Can Lead the Inspire Medical Systems Class Action
Two class actions followed, both covering a class period of August 6, 2024, through August 4, 2025. The first, filed in the District of Minnesota in November 2025 by the City of Pontiac Reestablished General Employees’ Retirement System, was voluntarily dismissed on December 29, 2025. 11CourtListener. City of Pontiac v. Inspire Medical Systems Docket The surviving case, Indiana Public Retirement System v. Inspire Medical Systems, Inc., No. 25-cv-10620 (S.D.N.Y.), was filed December 22, 2025, by Bernstein Litowitz Berger & Grossmann LLP. 12BLB&G. BLB&G – Inspire Medical Systems Investigation
The complaint names CEO and Chairman Timothy Herbert, CFO Richard Buchholz, and Chief Strategy and Growth Officer Carlton Weatherby as individual defendants. Investors allege the executives repeatedly told the market the launch was on track. Herbert told investors in January 2025 that feedback from the soft launch was “tremendous” and the company was “at the cusp” of a full launch; in February 2025, he stated the SleepSync system was fully launched in the U.S. 13Levi & Korsinsky. Inspire Medical Systems Securities Class Action Lawsuit Filed The lawsuit contends these statements were misleading because the executives knew centers lacked required training, critical IT systems were not in place, and Medicare reimbursement was not functional at launch. 12BLB&G. BLB&G – Inspire Medical Systems Investigation
The lead plaintiff deadline passed on January 5, 2026. Inspire has said it intends to “vigorously defend itself.” 7MassDevice. Inspire Medical Faces Investor Class Action
The reimbursement problem deepened after the disclosure. In December 2025, two Medicare administrative contractors removed the newer CPT code 64568 for Inspire V and reverted billing to the older code 64582, which pays less. The reversal wiped out a projected 50–60% increase in facility fees and pushed the stock down roughly another 20%. 14Trefis. Inspire Medical Stock: Medicare Reimbursement Reversal Jolts Investors In February 2026, the company confirmed Inspire V procedures should be billed under CPT code 64582 with a reduced-services modifier, which it estimated would cut professional fees by 10% to 50%. Inspire acknowledged the reduction was likely to “influence physicians’ willingness to perform the Inspire V procedure” and revised its 2026 revenue outlook. 15Sleep Review. Inspire Medical Systems Clarifies Coding for Inspire V
The DOJ Civil Investigation
In January 2025, Inspire received a civil investigative demand from the U.S. Attorney’s Office for the District of Minnesota. The company disclosed the probe on February 10, 2025, during its fourth-quarter 2024 earnings call. 16Fierce Biotech. Inspire Medical Discloses DOJ Civil False Claims Investigation
The DOJ is investigating allegations of false claims submitted to government payers, specifically potential violations of the Anti-Kickback Statute, and is seeking documents about the company’s “marketing, promotion and reimbursement practices” for its sleep apnea implants. 17MedTech Dive. Inspire Medical DOJ Civil Investigation This is a civil inquiry, not a criminal charge, and no complaint has been filed.
Herbert stated the company would “fully cooperate with the investigation” and expressed confidence in its compliance programs. He said Inspire had not changed its selling practices and did not expect the probe to affect operations. No settlement, charges, or resolution had been publicly announced as of mid-2026. 17MedTech Dive. Inspire Medical DOJ Civil Investigation
The Earlier Investor Case Was Dismissed
A separate investor suit filed in late 2023 is sometimes confused with the current one. The City of Hollywood Firefighters’ Pension Fund sued in the District of Minnesota (No. 23-cv-03884), alleging Herbert and Buchholz made misleading statements about an “Acceleration Program” designed to streamline scheduling for patients seeking Inspire therapy. The class period ran from May 3, 2023, through November 7, 2023. 18Saxena White. Saxena White Files Securities Fraud Class Action Against Inspire Medical Systems
In March 2025, Judge Nancy E. Brasel dismissed the case with prejudice, ruling that the plaintiff “failed to adequately allege false statements or fraudulent intent.” 19Faegre Drinker. Inspire Medical Systems Wins Dismissal With Prejudice of Alleged 34 Act Violations Because the dismissal was with prejudice, the claims cannot be refiled. The current Inspire V investor case is a different lawsuit with a different class period and different allegations.
The Patent Fight With Nyxoah
Inspire is also in a patent dispute with Nyxoah, a Belgium-based competitor whose battery-free Genio nerve stimulation implant recently received FDA approval. Inspire sued in Delaware federal court on May 30, 2025, alleging the Genio system infringes three of its neurostimulation patents and seeking an injunction to keep the device off the U.S. market. 20Fierce Biotech. Nyxoah Plans US Launch Sleep Apnea Implant; Rival Inspire Lobs Patent Suit Nyxoah countersued in September 2025, asserting that the Inspire IV and Inspire V devices infringe three Nyxoah patents. 21MassDevice. Nyxoah Patent Infringement Countersuit Against Inspire Medical
In November 2025, Magistrate Judge Eleanor G. Tennyson disqualified Latham & Watkins from representing Inspire, finding the firm had obtained “highly relevant” confidential information about Nyxoah’s Genio device while advising underwriters during Nyxoah’s prior stock offerings. 22Bloomberg Law. Latham & Watkins Disqualified in Inspire IP Suit Against Nyxoah Inspire filed objections in December 2025, and some case deadlines were stayed. As of early 2026, no preliminary injunction had issued. 23CourtListener. Inspire Medical Systems v. Nyxoah Docket
Where Things Stand
As of mid-2026, four proceedings are active. The Southern District of New York securities case over the Inspire V launch is in its early stages after the January 2026 lead plaintiff deadline. The DOJ’s civil investigation into marketing and reimbursement practices is open with no announced resolution. The Luquette product liability case in Louisiana is proceeding toward Inspire’s answer. The patent dispute with Nyxoah in Delaware has been slowed by the disqualification of Inspire’s original counsel. In its 2025 10-K, the company acknowledged that “ongoing litigation and potential government investigations pose financial and reputational threats.” 24TradingView. Inspire Medical Systems SEC 10-K Report
If you have an Inspire implant and are worried about the recall or a possible malfunction, contact your implanting physician; the recall population is small and the device serial number determines whether yours is affected. If you experienced an adverse event you believe was caused by the device, a product liability attorney in your state can tell you whether your facts resemble the Luquette allegations closely enough to support a claim.