ProSomnus EVO Sleep and Snore DeviceRecalls & reported problems
Prosomnus Sleep Technologies · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00863039000485), received between Mar 14, 2025 and Jan 19, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (2 reports).
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.
Reports received per month
Most reported problems
Device problems
- Break2
- Adverse Event Without Identified Device or Use Problem1
- Detachment of Device or Device Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Bruxism1
- Tooth Fracture1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 19, 2026Break
PROSOMNUS SLEEP TECHNOLOGIES RECEIVED VOLUNTARY MEDWATCH REPORT MW5180513 DATED JANUARY 8TH, 2026, FROM US FDA / CDRH; BELOW IS THE EVENT OR PROBLEM STATEMENT VERBATIM EXTRACTED FROM THAT REPORT. "A JAGGED FRAGMENT BROKE OFF OF MY PROSOMNUS SLEEP APNEA DEVICE WHILE I WAS SLEEPING AND WAS LOOSE IN MY MOUTH. I WAS ABLE TO WAKEN AND RETRIEVE THE FRAGMENT BEFORE SUCKING IT INTO MY AIRWAY. I HAVE NOT BEEN ABLE TO SLEEP WELL SINCE THE INCIDENT DUE TO DISTRESS AND MENTAL ANGUISH OVER THIS."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24111914 ↗MalfunctionNov 10, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
PROSOMNUS SLEEP TECHNOLOGIES RECIEVED MEDWATCH # MW5176206 DIRECTLY FROM THE FDA/CDRH ON (B)(6) 2025; BELOW IS THE EVENT DESCRIPTION RE-COPIED FROM THE REPORT. PROSOMNUS ORAL MANDIBULAR ADVANCEMENT TRAY HAD A PIECE BREAK OFF. IT IS A SET OF TWO TRAYS THAT SIT OVER THE TEETH AND TREAT SLEEP APNEA BY ADVANCING THE JAW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23514401 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PROSOMNUS SLEEP TECHNOLOGIES WAS MADE AWARE OF AN INCIDENT OF ROOT CANALED TOOTH BREAKAGE ON (B)(6) 2025 THAT OCCURRED ON (B)(6) 2025. PATIENT BROKE TOOTH # 9, PRESUMABLY AT THE GUMLINE, DUE TO EXCESS PRESSURE THE DAY AFTER DEVICE DELIVERY. HE WENT TO HIS GENERAL DENTIST AND IT [TOOTH # 9] WAS EXTRACTED AND AN IMPLANT WAS PLACED.
Patient problems: Bruxism; Tooth Fracture
MAUDE report 21612792 ↗
Other Device, Anti-Snoring devices
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- 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
- SICAT OPTISLEEP 10401SiCAT GmbH & Co. KG · 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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