ProSomnus EVO Sleep and Snore Device with Patient Monitoring EVO with Patient MonitoringRecalls & reported problems
Prosomnus Sleep Technologies · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863039000492), received between Sep 13, 2023 and Sep 13, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Incorrect Control/Treatment Settings” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Use of Incorrect Control/Treatment Settings1
Patient problems
- Sleep Dysfunction1
- Weight Changes1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 13, 2023Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings
PROSOMNUS SLEEP TECHNOLOGIES IS THE MANUFACTURER OF MANDIBULAR ADVANCEMENT DEVICES FOR THE TREATMENT OF OBSTRUCTIVE SLEEP APNEA AND SNORING. THE PATIENT REPORTED TO FDA ABOUT PROSOMNUS DEVICE IS SUSPECTED TO HAVE AN ADVERSE OUTCOME. FDA FORWARDED THE REPORT TO PROSOMNUS ON 08/24/2023. THE PATIENT REPORTED SLEEP DYSFUNCTION AND WEIGHT CHANGES FROM USING PROSOMNUS DEVICE. THE PATIENT REPORTED MONITORING SLEEP APNEA EPISODES USING A PULSE OXIMETER PURCHASED FROM EBAY. PATIENT ALSO REPORTED LOSING 20 LBS OF BODY WEIGHT AND THE DEVICE IS NOT INTENDED TO LOSE WEIGHT OR CURE OBSTRUCTIVE SLEEP APNEA. PROSOMNUS SLEEP DEVICES ARE USED TO ALLEVIATE OBSTRUCTIVE SLEEP APNEA AND SNORING AS THE INDICATIONS STATE. ELIMINATING THE USE OF SUPPLEMENTAL OXYGEN MUST ONLY BE DONE UNDER MEDICAL ADVICE OR SUPERVISION. THE PATIENT'S SERIOUS ALLEGATIONS HAS LITTLE OR NO PROOF AS THERE IS ENOUGH CLINICAL EVIDENCE IN ALLEVIATING OBSTRUCTIVE SLEEP APNEA FROM USING PROSOMNUS DEVICES. THE PATIENT ALSO REPORTED TO FDA ABOUT THE USE OF PROSOMNUS DEVICE WITH PATIENT MONITORING. AFTER INVESTIGATING FURTHER, THE DEVICE PRESCRIBED BY THE PATIENT'S DENTIST DID NOT HAVE A PATIENT MONITORING SENSOR EMBEDDED IN THE DEVICE
Patient problems: Sleep Dysfunction; Weight Changes
MAUDE report 17741540 ↗
Other Device, Anti-Snoring devices
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- ProSomnus EVO Sleep and Snore DeviceProsomnus Sleep Technologies · Device, Anti-Snoring3 reports
- Flex F3000Somnomed, Inc. · Device, Anti-Snoring2 reports
- AIRvance® 76353200MMedtronic Xomed, Inc. · Device, anti-snoring2 reports
- The Panthera Anti-Snoring Device 1Panthera Dentaire Inc · Device, Anti-Snoring1 report
- Pink Series - EF SP030USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
- Respire Pink+ Hard SPP000USRespire Medical Holdings LLC · Device, Anti-Snoring1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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