Prosomnus CA 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00863039000409), received between Jun 10, 2022 and Jun 10, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
Patient problems
- Tooth Fracture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 10, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
THE DEVICE WAS TOO TIGHT ON TRY IN. THE INCISAL EDGE OF TOOTH #8 WAS FRACTURED.
Patient problems: Tooth Fracture
MAUDE report 14651872 ↗
Other Device, Anti-Snoring devices
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- Pink Series - H/S SP020USRespire Medical Holdings LLC · Device, Anti-Snoring3 reports
- 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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