Dornier MedTech THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USERecalls & reported problems
Dornier Medtech America, Inc. · THULIO LL-R TM 270µM 3M SLIM PERF. 3ST 10X USE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00810116023462), received between Sep 10, 2024 and Mar 3, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- No Apparent Adverse Event2
- Break1
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.
MalfunctionMar 3, 2026Break
DMTA RECEIVED A REPORT THAT A FIBER BROKE DURING A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24501218 ↗MalfunctionDec 2, 2024No Apparent Adverse Event; No Apparent Adverse Event
ON 5 NOVEMBER 2024 DMTA QUALITY WAS CONTACTED REGARDING A THULIO LASER FIBER WHICH WAS REPORTED TO HAVE BROKEN ON 26 SEPTEMBER 2024. NO PATIENT IMPACT WAS REPORTED AS A RESULT OF THE REPORTED FIBER BREAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20825260 ↗MalfunctionSep 10, 2024No Apparent Adverse Event; No Apparent Adverse Event
TWO HOLMIUM FIBERS WERE REPORTED TO BE DAMAGED AND BROKEN. THE CUSTOMER STATED REGARDING ONE UNIT, "FIBER WAS VISIBLY DAMAGED AT SEVERAL POINTS AND COULD NOT BE USED IN THE PROCEDURE". THE OTHER UNIT WAS DESCRIBED, "FIBER HAS BEEN BROKEN JUST BEFORE TREATMENT WHEN HEALTHCARE PROFESSIONALS WERE CONNECTING IT TO THE LASER".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20183676 ↗
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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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