WaveOne Gold Glider TSTW1GG325015Recalls & reported problems
Tulsa Dental Products LLC · WaveOne Gold Glider - 3pk - 25mm · Class 1
All models of WaveOne Gold Glider (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 17
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI D716TSTW1GG3250151), received between Aug 8, 2023 and May 27, 2026 — classified as 17 malfunctions.
The most frequently reported specific device problem is “Break” (17 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
- Break17
Patient problems
- Device Embedded In Tissue or Plaque15
- No Clinical Signs, Symptoms or Conditions2
- Insufficient Information1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25 MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED AND THE PATIENT WAS REFERRED TO AN ENDODONTIST FOR FURTHER TREATMENT. REPORTEDLY, NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25299367 ↗MalfunctionAug 18, 2025Break; Break
IN THE EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22828798 ↗MalfunctionAug 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART HAS NOT BEEN RETRIEVED FROM PATIENT'S MOUTH. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22795062 ↗MalfunctionAug 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART HAS BEEN RETRIEVED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22794871 ↗MalfunctionJul 23, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25 MM BLISTER 6 FILE BROKE DURING USE. THE OUTCOME OF THIS EVENT IT UNKNOWN AS OF THIS MDR. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 22574465 ↗MalfunctionMay 21, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART WAS LEFT IN THE TOOTH AND WAS INCORPORATED INTO THE FILLING.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22063720 ↗MalfunctionMay 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. DOCTOR WAS WORKING ON A CALCIFIED CANAL ON TOOTH #5, APPROXIMATELY 3MM OF THE TIP BROKE NEAR THE APEX. DOCTOR FILLED BEHIND. FILE WAS DISCARDED. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22025229 ↗MalfunctionMay 15, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. CASE 1 OF 2.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22025066 ↗MalfunctionNov 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT 2 WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILES BROKE DURING USE. THE BROKEN PARTS COULD NOT BE RETRIEVED. FURTHER TREATMENT IS EXPECTED. NO INJURY OCCURRED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 20664876 ↗MalfunctionSep 12, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20200517 ↗MalfunctionJun 26, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. THE BROKEN PART WAS NOT RETRIEVED. THE CANAL WAS TREATED AND THE PATIENT WILL RETURN FOR FURTHER TREATMENT. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19613379 ↗MalfunctionJun 20, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE CANAL. PATIENT REFERRED TO SPECIALIST. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19578697 ↗MalfunctionJun 20, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. PATIENT WAS REFERRED TO A SPECIALIST FOR REMOVAL. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 19574362 ↗MalfunctionJan 23, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVE ONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. THE BROKEN PARTS COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18567162 ↗MalfunctionDec 4, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD GLIDER 015-02/25MM BLISTER 6 FILE BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED. NO INJURY FROM ALLEGED EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 18255550 ↗MalfunctionAug 30, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT A WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US BROKE DURING USE. THE BROKEN PART COULD NOT BE RETRIEVED AND WAS INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17651307 ↗MalfunctionAug 8, 2023Break; Break
IN THIS EVENT IT IS REPORTED THAT WAVEONE GOLD GLIDER 015-02/25MM BLISTER 3 US FILE BROKE DURING USE. THE BROKEN PART REMAINS IN THE ROOT CANAL AND INCORPORATED INTO THE FILLING. NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 17481405 ↗
Other FILE, PULP CANAL, ENDODONTIC devices
- WaveOne Gold Rotary File WGPRIME25Tulsa Dental Products LLC · FILE, PULP CANAL, ENDODONTIC68 reports
- EdgeTaper SETF225US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall1 report
- Brasseler USA 5026670U0Peter Brasseler Holdings, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES900425US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- 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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