Cavitron® 81551Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® THINsert® Ultrasonic Insert 30K THINSERT® · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI D003815511), received between Aug 22, 2023 and Aug 23, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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 Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 23, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAVITRON THINSERT, PACKED TIP GET HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20048826 ↗MalfunctionJun 19, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K CAVITRON THINSERT, PACKED GOT HOT WITH NO WATER COMING OUT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566226 ↗MalfunctionApr 9, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAVITRON THINSERT, PACKED HAS NO VIBRATION AND GET HOT IMMEDIATELY. NO INJURY REPORTED FROM ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19069640 ↗MalfunctionAug 22, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K CAVITRON THINSERT,PACKED ALLEGEDLY INSERT GETS EXTREMELY HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596127 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.