LightTrail™ Single Use M0068F64520Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729939771), received between Dec 27, 2018 and Jan 26, 2026 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionMay 26, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A LIGHTTRAIL SINGLE USE LASER FIBER WAS USED IN A LITHOTRIPSY PROCEDURE FOR A STONE TREATMENT IN THE URETER PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. DURING THE PROCEDURE, THE PHYSICIAN USED A RIGID URETEROSCOPE AND HEARD A NOISE. THE PHYSICIAN REMOVED THE SCOPE AND SAW THE LASER FIBER BODY BROKEN. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515090 ↗
• MalfunctionOct 21, 2021Break; Degraded; Break; Degraded

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER SUDDENLY WENT OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING THAT THE LASER FIBER WAS BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12673322 ↗
• MalfunctionFeb 23, 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 ON (B)(6) 2021 THAT A LIGHTTRAIL SINGLE USE 270UM LASER FIBER WAS USED IN A LITHIASIS PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2021. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL LASER CONSOLE. IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE LASER FIBER WAS NOT RECOGNIZED WHEN CONNECTED TO THE CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11365039 ↗
• InjuryFeb 4, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2021 THAT A LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS A DORNIER LASER CONSOLE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE FIBER TIP BROKE OFF. REPORTEDLY, THE FIBER TIP FELL INSIDE THE PATIENT'S BODY AND WAS UNABLE TO BE RETRIEVED. SINCE THE PHYSICIAN DID NOT THINK THE FIBER TIP WOULD PASS NATURALLY THE PATIENT WAS REFERRED TO A DIFFERENT DOCTOR AT A DIFFERENT HOSPITAL TO REMOVE THE FIBER TIP AT A LATER DATE. IT IS UNKNOWN IF THE PROCEDURE TO REMOVE THE FIBER TIP HAS BEEN PERFORMED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11278423 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2020 THAT A LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS DETERMINED THAT THERE WAS INSUFFICIENT VISUALIZATION DUE TO THE THICKNESS OF THE LIGHTTRAIL SINGLE USE 365UM LASER FIBER. THE PHYSICIAN REMOVED THE FIBER AND OPENED A LIGHTTRAIL SINGLE USE 270UM LASER FIBER TO COMPLETE THE PROCEDURE. AFTER THE PROCEDURE, A GUIDEWIRE WAS PASSED THROUGH THE SCOPE, AND THE BROKEN END OF THE LIGHTTRAIL SINGLE USE 365UM LASER FIBER CAME OUT OF THE SCOPE. THOUGH THE LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS FOUND TO HAVE BROKEN INSIDE THE SCOPE, THE LIGHTTRAIL SINGLE USE 270UM LASER FIBER HAD STILL BEEN ABLE TO PASS THROUGH THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS. **CORRECTION TO INFORMATION INITIALLY REPORTED** THE PROCEDURE PERFORMED WAS A LITHOTRIPSY PROCEDURE TO BREAK UP STONES. THE PHYSICIAN WAS ABLE TO USE THE LIGHTTRAIL SINGLE USE 270UM LASER FIBER TO FINISH BREAKI

  Patient problems: Insufficient Information; No Known Impact Or Consequence To Patient

  MAUDE report 10763053 ↗
• MalfunctionApr 7, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 18, 2020 THAT A LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS OPENED FOR USE FOR A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, THE TIP OF THE LASER FIBER WAS NOTED TO BE BROKEN UPON OPENING THE PACKAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIGHTTRAIL SINGLE USE 365UM LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9933222 ↗
• MalfunctionMar 30, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MARCH 09, 2020 THAT A LIGHTTRAIL SINGLE USE 365UM LASER FIBER WAS USED IN A CISTOLITOTRIPSIA PROCEDURE IN THE BLADDER PERFORMED ON (B)(6) 2020. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA 30 WATT LASER CONSOLE WITH LASER SETTINGS 800 MILLIJOULES AND 8 HERTZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN AND A SMALL PIECE OF GLASS FIBER, THE TIP, FELL INSIDE THE BLADDER OF THE PATIENT. REPORTEDLY, THE FIBER FRAGMENT, THE TIP, WAS RETRIEVED SUCCESSFULLY USING A CYSTOSCOPE. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9897786 ↗
• MalfunctionDec 27, 2018Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON DECEMBER 3, 2018 THAT A LIGHTTRAIL 365UM SINGLE USE LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6) 2018. REPORTEDLY, THE LASER UNIT USED WAS AN AURIGA XL 4007 CONSOLE WITH LASER SETTINGS OF 1 J AND 12 HZ. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE TIP OF THE LASER FIBER DETACHED INSIDE THE PATIENT UPON LASER ACTIVATION. REPORTEDLY, NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO 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 8199333 ↗