Cavitron® 82009Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® THINsert® FITGRIP® Ultrasonic Insert 30K THINSERT® FG · Class 2
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D003820091), received between Mar 30, 2023 and Feb 13, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (13 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device13
- No Flow6
- Restricted Flow rate2
Patient problems
- No Clinical Signs, Symptoms or Conditions17
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 13, 2026Restricted Flow rate
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG, PACKED IS ALLEGED TO HAVE LACK OF WATER FLOW AND OVERHEATING HANDPIECE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24331818 ↗MalfunctionFeb 9, 2026No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG HAS NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24292817 ↗MalfunctionJan 21, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED IS ALLEGED THAT IT OVERHEATED AND WATER BECAME TOO HOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24130450 ↗MalfunctionDec 9, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED ALLEGEDLY GOT HOT AND OVERHEATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758971 ↗MalfunctionOct 31, 2025Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG, PACKED USED BY A STUDENT IS ALLEGED THE INSERT HAS NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23435125 ↗MalfunctionSep 19, 2025No Flow; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED IS ALLEGED THE INSERT HAS NO WATER FLOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097078 ↗MalfunctionMay 19, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT WHILE A 30K CAV.THINSERT-FG, PACKED WAS USED IT IS ALLEGED THE TIP GOT SO HOT IT BURNT THE TIP DUE TO MECHANICAL ISSUE WITH THE CAVITRON. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22047653 ↗MalfunctionNov 26, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED ALLEGEDLY OVERHEATED AND HAS BAD WATER FLOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20784450 ↗MalfunctionNov 19, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV. THINSERT-FG, PACKED IT IS ALLEGED THAT THE DEVICE IS GETTING VERY HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20724013 ↗MalfunctionFeb 7, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED ALLEGEDLY HAD INTERMITTENT WATER FLOW AND OVERHEATING DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18659158 ↗MalfunctionJan 30, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED ALLEGEDLY OVERHEATED DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18607928 ↗MalfunctionDec 19, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED DURING USE ALLEGEDLY THE DEVICE IS NOT SPRAYING WATER AND GETS VERY HOT. NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18354790 ↗MalfunctionOct 24, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED ALLEGEDLY TIP GOT HOT AND NO WATER FLOW. NO INJURY REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994315 ↗MalfunctionJun 5, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED GOT HOT AND HAD NO WATER COMING OUT OF TIP DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17058357 ↗MalfunctionMay 22, 2023Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT 30K CAV.THINSERT-FG,PACKED OVERHEATS AND HAS NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973687 ↗MalfunctionMar 30, 2023Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED ALLEGEDLY GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16643634 ↗MalfunctionMar 30, 2023No Flow; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K CAV.THINSERT-FG,PACKED ALLEGEDLY DOES NOT SPRAY WATER AND GETS HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16642574 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.