Cavitron® 82004Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® PowerLINE® FITGRIP® Ultrasonic Insert 30K FSI®-PWR-1000 FG · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI D003820041), received between Nov 20, 2023 and Jul 14, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (5 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 Device5
- Restricted Flow rate2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 14, 2026Overheating of Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25810877 ↗MalfunctionApr 29, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-FG-1000 INSERT, PKD ALLEGED OVERHEATED DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25027221 ↗MalfunctionSep 19, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-FG-1000 INSERT, PKD ALLEGEDLY THE WATER WILL ONLY SPRAY IN A WIDE BAND WITH NO DRIP WITH SOAKING THE PATIENT. WHEN THE WATER IS TURNED DOWN THE TIP GETS HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097949 ↗MalfunctionSep 19, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
IN THIS EVENT IT IS REPORTED A 30K FSI-PWR-FG-1000 INSERT, PKD IS ALLEGED THAT THE WATER WILL ONLY SPRAY A WIDE BAND WITH NO DRIP WHICH SOAKS THE PATIENT. WHEN WATER IS TURNED DOWN THE TIP GETS HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097727 ↗MalfunctionOct 30, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-FG-1000 INSERT,PKD BROKE DURING USE. THE INSERT BEING USED BY A STUDENT, THE TIP BROKE OFF. NOT CERTAIN IF THIS HAPPENED DURING USE ON A PATIENT OR NOT. SINCE THE TIP WAS NOT LOCATED, PANORAMIC X-RAY DONE THE FOLLOWING DAY AND CHEST AND ABDOMINAL X-RAY IS ALSO SCHEDULED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20566358 ↗MalfunctionNov 20, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-PWR-FG-1000 INSERT,PKD GOT HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18170309 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.