Cavitron® 81308Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI D003813081), received between Nov 14, 2023 and Mar 24, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Restricted Flow rate” (11 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Restricted Flow rate

  WHILE USING A CAVITRON SELECT SPS G124, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE WATER AND THE HANDPIECE ARE GETTING WARM TO THE TOUCH; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674096 ↗
• MalfunctionMar 13, 2026No Flow

  WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24598257 ↗
• MalfunctionFeb 20, 2026Restricted Flow rate

  WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS GETTING HOT, NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401348 ↗
• MalfunctionDec 28, 2025Restricted Flow rate; Restricted Flow rate

  WHILE USING A CAVITRON SELECT SPS G124, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903726 ↗
• MalfunctionDec 28, 2025No Flow; No Flow

  WHILE USING A CAVITRON G124 GENERATOR(DNA), THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS GETTING WARM. NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903725 ↗
• MalfunctionDec 28, 2025Restricted Flow rate; Restricted Flow rate

  WHILE USING A CAVITRON G124 GENERATOR(DNA), THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23903723 ↗
• MalfunctionJun 23, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device

  WHILE THE CUSTOMER WAS USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THE HANDPIECE AND THE INSERT TIP ARE OVERHEATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22306579 ↗
• MalfunctionJun 10, 2025Restricted Flow rate; Restricted Flow rate

  WHILE THE CUSTOMER WAS USING A CAVITRON SELECT SPS G124, THEY ALLEGE THAT THEY HAVE INSUFFICIENT WATER FLOW AND THE HANDPIECE IS GETTING WARM. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22180348 ↗
• MalfunctionMay 21, 2025Restricted Flow rate; Restricted Flow rate

  WHILE USING A CAVITRON SELECT G124 THEY ALLEGE THAT THEY HAVE INCONSISTENT WATER FLOW AND THE HANDPIECE HEATED UP; NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22065857 ↗
• MalfunctionMay 19, 2025Overheating of Device; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT WHILE A CUSTOMER WAS USING A CAV.SELECT SPS SWVL 230V-UK/I THEY ALLEGED THE INSERTS WERE GETTING HOT DURING USE. NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047179 ↗
• MalfunctionMay 28, 2024Overheating of Device; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT SELECT SPS SWVL/RESRV,230VUK/I ALLEGEDLY THE INSERTS ARE GETTING HOT WITH THE DEVICE DURING USE. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19403598 ↗
• MalfunctionApr 18, 2024Restricted Flow rate; No Flow; Restricted Flow rate; No Flow

  WHILE USING A CAVITRON SELECT WITH RESERVOIR G123 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE GETS HOT, NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132624 ↗
• MalfunctionApr 5, 2024Restricted Flow rate; No Flow; Restricted Flow rate; No Flow

  WHILE USING A CAVITRON JET PLUS G137, THEY ALLEGE THAT NOT ENOUGH WATER IS GETTING TO THE HANDPIECE AND THE HANDPIECE GETS HOT,NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19053733 ↗
• MalfunctionFeb 5, 2024Overheating of Device; Overheating of Device

  WHILE THE CUSTOMER WAS USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT THE UNIT WAS LEAKING WATER AND THE HANDPIECE AND INSERT TIP WAS RUNNING HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638986 ↗
• MalfunctionJan 22, 2024Overheating of Device; No Flow; Overheating of Device; No Flow

  WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT NO WATER IS GOING THROUGH THE UNIT AND THE HANDPIECE IS GETTING WARM, NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18556633 ↗
• MalfunctionJan 18, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT SELECT SPS SWVL/RESRV,230VUK/I HAVING REDUCED WATER FLOW ISSUE AND THE INSERT IS OVERHEATING. NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18535120 ↗
• MalfunctionJan 18, 2024Restricted Flow rate; Restricted Flow rate

  IN THIS EVENT IT IS REPORTED THAT SELECT SPS SWVL/RESRV,230VUK/I NOT ENOUGH WATER COMING THROUGH HANDPIECE AND CAN NOT CONTROL HOW MUCH WATER IS COMING THROUGH. HANDPIECE IS OVERHEATING ALSO.

  Patient problems: Insufficient Information

  MAUDE report 18534906 ↗
• MalfunctionNov 30, 2023No Flow; No Flow

  WHILE USING A CAVITRON SELECT SPS G124 THEY ALLEGE THAT NO WATER AT THE HANDPIECE CAUSING THE HANDPIECE TO GET HOT,NO INJURY RESULTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18236450 ↗
• MalfunctionNov 14, 2023Overheating of Device; Overheating of Device

  IN THIS EVENT IT IS REPORTED THAT WHILE A CUSTOMER WAS USING SELECT SPS SWVL/RESRV,230VUK/I DURING TREATMENT IT IS ALLEGED THAT THE CAVITRON TIP WAS HOT AND THE PATIENT'S LIP FELT A BURNING SENSATION. REPORTEDLY, NO INJURY.

  Patient problems: Burn(s)

  MAUDE report 18132936 ↗