Vortex Blue Rotary File VTB042525Recalls & reported problems
Tulsa Dental Products LLC · Vortex Blue 04/25 25mm · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 D716VTB0425251), received between Jan 3, 2024 and Apr 24, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break4
Patient problems
- Device Embedded In Tissue or Plaque3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT PROFILE VORTEX BLUE 04/25 25MM BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 21899228 ↗MalfunctionJan 5, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROFILE VORTEX BLUE 04/25 25MM FILE BROKE DURING USE AT MID ROOT ON TOOTH #3. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY. THE FILE WAS DISCARDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18457607 ↗MalfunctionJan 5, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROFILE VORTEX BLUE 04/25 25MM FILE BROKE DURING USE. THE FILE BROKE DURING A PROCEDURE MID ROOT ON TOOTH #3. THE BROKEN PART WAS NOT RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.THE FILE WAS DISCARDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18457466 ↗MalfunctionJan 3, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT PROFILE VORTEX BLUE 04/25 25MM FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IS UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Insufficient Information
MAUDE report 18441152 ↗
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- EdgeTaper SET25MMUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Brasseler USA 5026667U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeOne Fire SEOFAST21US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- Edge File SX7300625RFUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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