Cavitron® 80798Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® PowerLINE® Ultrasonic Insert 30K FSI®-PWR-100 · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI D003807981), received between Jun 16, 2023 and Jan 13, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (2 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 Device2
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 13, 2026No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-100 INSERT,PACKED IS ALLEGED TO HAVE NO WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24058298 ↗MalfunctionAug 10, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-PWR-100 INSERT,PACKED INSERT TIP IS OVERHEATING. NO INJURY OCCURRED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17497686 ↗MalfunctionJun 16, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-PWR-100 INSERT,PACKED IS ALLEGED TO BE HEATING UP DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17142393 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.