LightTrail™ Single Use M0068F64500Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729939764), received between Dec 20, 2018 and Jun 15, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 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.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THIS FIBER BROKE TWICE DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE AND/OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381075 ↗
• MalfunctionOct 24, 2025Break; Break

  IT WAS REPORTED THAT THIS FIBER BROKE TWICE DURING THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING PROCEDURE AND/OR PATIENT OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23380855 ↗
• MalfunctionMar 12, 2025Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING PREPARATION, THE FIBER EXPLODED WITH A SPARK AFTER CONFIRMING THE SETTINGS TO READY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21589388 ↗
• MalfunctionNov 2, 2021Connection Problem; Appropriate Device Problem Term/Code Not Available; Connection Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AURIGA XL 4007 CONSOLE AND TWO LIGHTTRAIL SINGLE USE LASER FIBERS WERE USED DURING A FLEXIBLE URETEROSCOPY PROCEDURE TO TREAT KIDNEY STONES ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS ABOUT TO USE THE FIBER, ERROR CODE 1103- "FIBER IDENTIFICATION FAILED" DISPLAYED ON THE AURIGA CONSOLE, MAKING IT IMPOSSIBLE TO USE THE FIRST LASER FIBER. A SECOND LIGHTTRAIL SINGLE USE LASER FIBER WAS OPENED FOR THE PROCEDURE, HOWEVER THIS LASER FIBER WAS ALSO NOT ABLE TO BE USED DUE TO THE CONSOLE ERROR MESSAGE. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739864 ↗
• MalfunctionMay 28, 2021Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A LIGHTTRAIL SINGLE USE 230UM LASER FIBER WAS USED IN LASER LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2021. THE LASER UNIT USED WAS AN AURIGA 30 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER BROKE DURING LASER ACTIVATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 230UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11900627 ↗
• MalfunctionApr 8, 2021Degraded; Material Deformation; Degraded; Material Deformation

  IT WAS REPORTED TO BOSTON SCIENTIFIC, THAT A LIGHTTRAIL SINGLE USE 230UM LASER FIBER WAS USED IN A FLEXIBLE URETEROSCOPY (FURS) PROCEDURE. PERFORMED ON (B)(6) 2021. THE LASER UNIT USED, WAS AN AURIGA 30 LASER CONSOLE. DURING THE PROCEDURE, AS SOON AS THE FIBER CAME INTO VIEW ON THE SCOPE. IT WAS NOTED, THAT THE LASER FIBER TIP WAS DAMAGED. THE PHYSICIAN WAS ABLE TO FIRE THE FIBER, BUT WAS UNSATISFIED WITH THE EFFICIENCY. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 230UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637264 ↗
• MalfunctionMay 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2019 THAT A LIGHTTRAIL 230UM LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2019. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA 30 CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER DETACHED INSIDE THE PATIENT. REPORTEDLY, THE BROKEN TIP WILL BE OUT PASSED NATURALLY. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO SERIOUS INJURY NOR ADVERSE PATIENT EFFECTS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8568430 ↗
• InjuryDec 20, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON NOVEMBER 30, 2018 THAT A LIGHTTRAIL SINGLE USE 230UM LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE IN THE KIDNEY PERFORMED ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE LASER FIBER WAS PLUGGED INTO THE LASER AND INSERTED THROUGH A URETEROSCOPE. AFTER 5 MINUTES INTO THE PROCEDURE, THE GLASS TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT'S KIDNEY. THE SURGEON USED A NITINOL BASKET TO RETRIEVE THE GLASS TIP AND WAS SUCCESSFUL WITHOUT AND HARM TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LASER FIBER. THERE WERE NO ADVERSE PATIENTS EFFECTS AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8187073 ↗