M-access® HEDSTROEM FILE A16MA02501012Recalls & reported problems
MAILLEFER INSTRUMENTS HOLDING Sàrl · Endodontic Instrument · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI J003A16MA025010121), received between Nov 25, 2024 and Nov 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Device Embedded In Tissue or Plaque1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2025Break; Break
IN THIS EVENT IT IS REPORTED THAT A HEDSTROEM M-ACCESS 25MM 010 FILE BROKE DURING USE. THE DOCTOR REPLACED THE FILE WITH A NEW ONE AND CONTINUED THE TREATMENT. NO PATIENT INJURY. FURTHER INFORMATION REQUESTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23542385 ↗InjuryNov 25, 2024Break; Break
IN THIS EVENT IT IS REPORTED THAT A HEDSTROEM M-ACCESS 25MM 010 BROKE DURING USE. THE TIP OF THE FILE WAS FOUND AN X-RAY EXAMINATION THAT WAS DONE AT A FOLLOW-UP VISIT. FOLLOWING THE BREAKAGE, THERE WAS AN ABSCESS IN THE GINGIVAL AREA ON THE BUCCAL SIDE OF THE LEFT UPPER POSTERIOR TOOTH, WHICH AFFECTED THE LEFT CHEEK AND CAUSED SIGNIFICANT PAIN. INCISION AND DRAINAGE OF BUCCAL ABSCESS WERE DONE DUE TO THE HIGH DIFFICULTY OF REMOVING THE BROKEN FILE. FOLLOWED BY DENTAL TREATMENT, OBSERVATION OF THE BROKEN NEEDLE, CONSERVATIVE TREATMENT, AND OUTPATIENT FOLLOW-UP. FURTHER INFORMATION REQUESTED.
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Unspecified Infection
MAUDE report 20773098 ↗
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- EdgeTaper Platinum SETS125HTUS Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeSequel Sapphire SES500421US Endodontics, LLC · FILE, PULP CANAL, ENDODONTIC1 recall0 reports
- EdgeTaper SETF321US 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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