LightTrail Single UseRecalls & reported problems across all models
Boston Scientific Corporation · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 142
- Deaths reported
- 0
- Injuries reported
- 12
- Recalls
- 0
We found 5 models of LightTrail Single Use by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 142 adverse event reports in the FDA's MAUDE database, received between Feb 21, 2018 and Jun 15, 2026 — classified as 12 injuries, 130 malfunctions.
The most frequently reported specific device problem is “Break” (92 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported LightTrail Single Use problems
Device problems
- Break92
- Degraded26
- Detachment of Device or Device Component21
- Overheating of Device11
- Connection Problem10
- Appropriate Device Problem Term/Code Not Available8
- Adverse Event Without Identified Device or Use Problem5
- Misfire5
Patient problems
- No Clinical Signs, Symptoms or Conditions92
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient10
- Insufficient Information6
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Burn(s)1
- Device Embedded In Tissue or Plaque1
LightTrail Single Use models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LightTrail™ Single Use M0068F64640Powered laser surgical instrument94 reports
- LightTrail™ Single Use M0068F64540Powered laser surgical instrument25 reports
- LightTrail™ Single Use M0068F64500Powered laser surgical instrument12 reports
- LightTrail™ Single Use M0068F64520Powered laser surgical instrument9 reports
- LightTrail™ Single Use M0068F64560Powered laser surgical instrument2 reports
Recent LightTrail Single Use adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2026Break
IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25512799 ↗MalfunctionMay 11, 2026Overheating of Device
IT WAS REPORTED THAT DURING THE PROCEDURE, THE LEAD BEGAN TO HEAT UP AND "BURN" UPON CONTACT WITH THE DEVICE. THE MACHINE WAS TURNED OFF, AND THE LEAD WAS REPLACED BEFORE RESUMING THE PROCEDURE. THE DURATION OF THE PROCEDURE WAS EXTENDED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25144332 ↗MalfunctionApr 15, 2026Power Problem
IT WAS REPORTED THAT DURING INTERVENTION, THIS DEVICE FUNCTIONED ONLY FIVE MINUTES THEN STOPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24891616 ↗MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING PROCEDURE, THE LASER FIBER BROKE DURING USE. ANOTHER FIBER NEEDED TO BE USED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24744576 ↗InjuryMar 25, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP BROKE OFF IN THE KIDNEY DURING USE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 24690915 ↗InjuryMar 19, 2026Break
IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER WAS NOT FUNCTIONING. UPON REMOVAL OF THE FIBER, IT WAS FOUND THAT A PART OF IT REMAINED IN THE PATIENT'S BODY. THIS PART WAS SUCCESSFULLY REMOVED. IT WAS NOTED THAT THE FIBER APPEARED TO BE SEVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER THE SAME FIBER. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24639067 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24553015 ↗MalfunctionMar 9, 2026Break
IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE WHILE IN USE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24546023 ↗MalfunctionFeb 20, 2026Nonstandard Device
IT WAS REPORTED THAT ONE LIGHTTRAIL DEVICE WAS RETURNED. THERE WAS NO REPORT OF PATIENT OR PROCEDURE INVOLVED. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE FIBER BODY WAS BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24402557 ↗MalfunctionJan 26, 2026Break; Overheating of Device
IT WAS REPORTED THAT THE FIBER OVERHEATED AT THE DEVICE CONNECTION POINT, CAUSING IT TO MELT AND BREAK. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24183508 ↗MalfunctionJan 9, 2026Material Integrity Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER WAS DAMAGED. THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A BROKEN FIBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24020772 ↗MalfunctionJan 6, 2026Break
IT WAS REPORTED THAT DURING INSERTION, THE FIBER BROKE WITHOUT BEING BENT OR DAMAGED. THERE WERE NO FRAGMENTS THAT FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23981090 ↗MalfunctionDec 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE ERROR MESSAGE: FAILURE1103 WAS DISPLAYED. THREE FIBERS WERE USED, AND DUE TO MULTIPLE FAILURES, THE PATIENT'S PROCEDURE HAD TO BE CANCELLED AND POSTPONED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865390 ↗MalfunctionDec 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE ERROR MESSAGE: FAILURE 1103 WAS DISPLAYED. THREE FIBERS WERE USED, AND DUE TO MULTIPLE FAILURES, THE PATIENT'S PROCEDURE HAD TO BE CANCELLED AND POSTPONED. PATIENT WAS UNDER GENERAL ANESTHESIA, PATIENT OUTCOME UNKNOWN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865382 ↗MalfunctionDec 22, 2025Communication or Transmission Problem; Communication or Transmission Problem
IT WAS REPORTED THAT DURING A PROCEDURE, THE ERROR MESSAGE: FAILURE 1103 WAS DISPLAYED. THREE FIBERS WERE USED, AND DUE TO MULTIPLE FAILURES, THE PATIENT'S PROCEDURE HAD TO BE CANCELLED AND POSTPONED. PATIENT WAS UNDER GENERAL ANESTHESIA, PATIENT OUTCOME UNKNOWN. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23865368 ↗
Other Boston Scientific Corporation products
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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