LightTrail™ Single Use M0068F64640Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 08714729939801), received between Feb 21, 2018 and Apr 15, 2026 — classified as 7 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Break” (63 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionOct 28, 2025Device Displays Incorrect Message; Power Problem; Device Displays Incorrect Message; Power Problem

  IT WAS REPORTED THAT DURING USAGE, THE FIBER STOPPED DELIVERING ENERGY, AND ERROR M01 WAS PROMPTED. THERE WAS NO REPORT OF PATIENT OR PROCEDURE INVOLVED. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURED CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408083 ↗
• MalfunctionJul 18, 2025Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT A LIGHTTRAIL LASER FIBER MALFUNCTIONED DURING PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THE FIBER WAS RETURNED AND ANALYSIS PERFORMED. DURING THE ANALYSIS, IT WAS FOUND THAT THE CONNECTOR HAD AN INTERNAL CONNECTOR FRACTURE. THEREFORE, REPORTABILITY IS MET BASED ON THIS DEVICE FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543683 ↗
• MalfunctionJul 10, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT THE FIBER COULD NOT BE USED AT THE FACILITY DUE TO AN UNSPECIFIED DEFECT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THE FIBER WAS RECEIVED AND ANALYZED. DURING INITIAL INSPECTION OF THE FIBER, IT WAS IDENTIFIED THAT THE CONNECTOR NUT WAS SEPARATED FROM THE FIBER BODY; THEREFORE, THE REPORTABILITY CRITERIA ARE MET BASED ON THIS INVESTIGATION FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22476140 ↗
• InjuryJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE WITH STONE FRAGMENTATION, THE LAST 5 MM OF THE FIBER'S TIP BROKE AND REMAINED IN THE PATIENT. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PROCEDURE OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196515 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A FLEXIBLE URETEROSCOPY PROCEDURE WITH STONE FRAGMENTATION, THE FIBER'S TIP BROKE INSIDE THE PATIENT. IT WAS FOUND IN THE CHALICE AND MEASURED APPROXIMATELY 5 MM. IT WAS NOTED THAT THE BROKEN FIBER TIP WAS WITHDRAWN WITHOUT OBSTRUCTIONS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196511 ↗
• MalfunctionMay 8, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT AT THE BEGINNING OF THE PROCEDURE, THE DEVICE'S DISTAL TIP WAS DETACHED FROM THE COPPER TIP AND CONNECTING THE FIBER TO THE CONSOLE WAS IMPOSSIBLE. IT WAS NOTED THAT THE LASER CONNECTOR WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21989430 ↗
• MalfunctionApr 21, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE DURING ACTIVATION OF THE LASER DURING THE PROCEDURE. A 4 CM PIECE OF THE FIBER WAS RECOVERED FROM INSIDE THE PATIENT. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING THE SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873025 ↗
• MalfunctionFeb 13, 2025Power Problem; Power Problem

  IT WAS REPORTED THAT THE FIBER DID NOT WORK AFTER 17:46 MINUTES, 2,8888 WATTS, 8 JOULES, AND 13603 IMPULSES OF USE. THE CUSTOMER REPORTED THAT SURGICAL TREATMENT COULD NOT BE CONTINUED AND TREATMENT TO THE PATIENT WAS DISRUPTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21371826 ↗
• MalfunctionDec 17, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LASER WAS ACTIVATED, THE PILOT LIGHT WOULD NOT TURN ON NOR DELIVER ENERGY. IT WAS THEN NOTICED THAT THE ENERGY WAS ALREADY DELIVERED WHERE IT WAS CONNECTED TO THE GENERATOR. A SECOND FIBER WAS USED BUT THE PROCEDURE WAS NOT SUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS IS FOR THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20955842 ↗
• MalfunctionDec 17, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE LASER WAS ACTIVATED, THE PILOT LIGHT WOULD NOT TURN ON NOR DELIVER ENERGY. IT WAS THEN NOTICED THAT THE ENERGY WAS ALREADY DELIVERED WHERE IT WAS CONNECTED TO THE GENERATOR. A SECOND FIBER WAS USED BUT THE PROCEDURE WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20955827 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER BROKE. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608612 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE LASER FIBER BROKE AND A PIECE AT THE FRONT OF THE FIBER DROPPED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PIECE OF THE FIBER WAS RETRIEVED. THE FIBER WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486497 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE, THE LASER FIBER BROKE AND A PIECE AT THE FRONT OF THE FIBER BODY DROPPED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE FIBER PIECE WAS RETRIEVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19485170 ↗
• MalfunctionFeb 8, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER STOPPED WORKING SUDDENLY. ANALYSIS OF THE RETURNED FIBER IDENTIFIED A FIBER BODY BREAK AND A CONNECTOR FRACTURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18673297 ↗
• MalfunctionJan 2, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, BEFORE THE FIBER WAS PUT DOWN THE SCOPE TO FIBER, THE FIBER TIP WAS FOUND TO BE BROKEN WITH A HOLE IN THE BLACK INSULATION NEAR THE TIP OF THE FIBER. A SECOND FIBER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18432706 ↗
• MalfunctionDec 12, 2023Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ERROR DISPLAYED WHEN CONNECTING THE FIBER. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BREAK. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310831 ↗
• MalfunctionDec 1, 2023Connection Problem; Adverse Event Without Identified Device or Use Problem; Connection Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LITHOTRIPSY PROCEDURE, THE CONSOLE ISSUED AN ERROR WHEN THE FIBER WAS CONNECTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE WITHOUT PATIENT COMPLICATIONS. DEVICE ANALYSIS FOUND THAT THE FIBER WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248534 ↗
• MalfunctionOct 23, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FIBER WOULD NOT WORK AS IT HAD BROKEN AWAY FROM THE CONNECTOR. A NEW FIBER WAS USED TO COMPLETE THE TREATMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17993221 ↗