Cavitron® 82008Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® FITGRIP® Ultrasonic Insert 30K FSI®-SLI®-1000 FG · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI D003820081), received between May 22, 2023 and Mar 23, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (9 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 Device9
- Restricted Flow rate3
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 23, 2026No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD IS ALLEGED THAT THERE IS NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24662151 ↗MalfunctionJan 22, 2026Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD ALLEGEDLY OVERHEATED AND HAD LACK OF WATER FLOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24145041 ↗MalfunctionJun 19, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD INSERT ALLEGEDLY HAS WATER FLOW THAT IS NOT CORRECT AND GETS HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292313 ↗MalfunctionDec 28, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD IS ALLEGED TO HAVE GOTTEN VERY HOT, OVERHEATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031683 ↗MalfunctionOct 31, 2024Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS, PKD INSERT GETS WARM AND DOES NOT HAVE ADEQUATE WATER FLOW. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20577657 ↗MalfunctionApr 24, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-1000 INS, PKD ALLEGEDLY THE INSERT HEATING UP DURING USE IN PATIENT'S MOUTH. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19172358 ↗MalfunctionOct 30, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD GOT HOT DURING USE AND WAS NOT WORKING. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18028612 ↗MalfunctionJul 6, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-1000 INS, PKD GOT HOT, OVERHEATED DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17269146 ↗MalfunctionJun 5, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS, PKD HEATS UP DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17059090 ↗MalfunctionMay 22, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-1000 INS,PKD ALLEGEDLY GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16973044 ↗
Other Scaler, ultrasonic devices
- AIR-FLOW FT-230-2B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- AIR-FLOW-PIEZON FT-229HF-0B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- Cavitron® 81302Dentsply Professional · Scaler, ultrasonic67 reports
- Posterior CleanFlow Procedure Instrument with Matrices FG-013-00004Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- APM Procedure Instrument with Matrix FG-003-00011Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- Cavitron® 8184001Dentsply Professional · Scaler, ultrasonic49 reports
- Cavitron® 8161425Dentsply Professional · Scaler, ultrasonic45 reports
- Cavitron® 80395Dentsply Professional · Scaler, ultrasonic36 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page