Flexiva Pulse M006L8405910Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729978572), received between Jan 12, 2022 and Jan 16, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (7 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 25, 2023Open, Classified

   Manufactured with the incorrect component may result in lower power output and degradation or dimming of the aiming beam, leading to reduced efficiency of fiber performance. Continued use may cause overheating of the fiber connector, which could result in a burn, if touched

   Z-2228-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

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.

• MalfunctionJan 16, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT KIDNEY STONES, THERE WERE FIVE FIBERS THAT BROKE AND CRACKED WITHIN MINUTES OF USING THEM. FOR ALL FIBERS, IT WAS NOTED THAT THIS WAS THE FIRST TIME THEY HAD BEEN USED. ALL FIBERS WERE BROKEN AT THE GLASS TIP, HOWEVER IT WAS REPORTED THAT NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE FIBERS WERE REPLACED, AND THE PROCEDURE WAS COMPLETED USING ANOTHER FIBER. THERE WERE NO COMPLICATIONS OR INJURY TO THE PATIENT OR USERS. THIS REPORT IS FOR THE FIFTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095338 ↗
• MalfunctionAug 19, 2025Break; Break

  IT WAS REPORTED THAT THIS FIBER BROKE WHEN TRIED TO REMOVE FROM SHEATH. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22846055 ↗
• MalfunctionNov 27, 2024Break; Overheating of Device; Break; Overheating of Device

  IT WAS REPORTED THAT DURING A HOLMIUM LASER PROCEDURE TO TREAT AN ENLARGE PROSTATE, THE FIBER BODY OVERHEATED AND EXPLODED. THE PHYSICIAN REPLACED THE FIBER, AND COMPLETED THE PROCEDURE, WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798340 ↗
• MalfunctionNov 27, 2024Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE LASER FIBER WIRE BURST AND BURNED ITSELF IN HALF. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER AND NO REPORT OF PATIENT COMPLICATIONS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790603 ↗
• MalfunctionNov 19, 2024

  WHILE USING THE HOLMIUM LASER, THE LASER FIBER WIRE "BURST" AND BURNED ITSELF IN HALF. THE LASER WAS BEING USED INTRAOPERATIVELY IN THE PATIENT WHEN THIS OCCURRED. NO STAFF WERE HARMED, LASER FIBER SEQUESTERED. NEW LASER FIBER GIVEN. PATIENT DRAPE EVALUATED FOR BURNS OR HARM, NONE NOTED AT THE TIME OF THE EVENT. VENDOR CAME ONSITE TO PERFORM A SYSTEM CHECK AND OUTPUT VERIFICATION. THE HOLMIUM UNIT WAS FOUND TO BE OPERATING TO MANUFACTURER SPECIFICATIONS. THE VENDOR BELIEVES THE ISSUE WAS DUE TO A FAULTY OR DAMAGED FIBER. MANUFACTURER RESPONSE FOR LASER FIBER USED FOR LITHOTRIPSY, FLEXIVA PULSE. (PER SITE REPORTER) REPORT PENDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20722998 ↗
• MalfunctionJan 26, 2024Break; Optical Problem; Break; Optical Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, UPON PLUGGING THE DEVICE INTO THE LASER, THE AIMING BEAM WAS RED INSTEAD OF THE EXPECTED GREEN. THE FIBER WAS REPLACED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588069 ↗
• MalfunctionJun 13, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 19, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED IN A LASER LITHOTRIPSY PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, A BURNING SMELL WAS OBSERVED ON THE FIBER CONNECTOR. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674480 ↗
• MalfunctionMay 31, 2022Overheating of Device; Overheating of Device

  NOTE: THIS REPORT PERTAINS TO SECOND OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02945 FOR THE FIRST FLEXIVA PULSE LASER FIBER, THIS REPORT FOR THE SECOND FLEXIVA PULSE LASER FIBER & MFR REPORT # 3005099803-2022-02947 FOR THE THIRD FLEXIVA PULSE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT THREE FLEXIVA PULSE 242 LASER FIBERS WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLUGGED IN EACH OF THE LASER FIBERS AND STARTED FIRING, THE DEVICE STARTED SMOKING. THE FIBER CONNECTOR WAS NOTED TO BE HOT TO THE TOUCH. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA PULSE 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549862 ↗
• MalfunctionMay 31, 2022Overheating of Device; Overheating of Device

  NOTE: THIS REPORT PERTAINS TO THIRD OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER MFR. REPORT # 3005099803-2022-02945 FOR THE FIRST FLEXIVA PULSE LASER FIBER, MFR REPORT # 3005099803-2022-02946 FOR THE SECOND FLEXIVA PULSE LASER FIBER & MFR REPORT FOR THE THIRD FLEXIVA PULSE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022. THAT THREE FLEXIVA PULSE 242 LASER FIBERS WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLUGGED IN EACH OF THE LASER FIBERS AND STARTED FIRING, THE DEVICE STARTED SMOKING. THE FIBER CONNECTOR WAS NOTED TO BE HOT TO THE TOUCH. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA PULSE 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549853 ↗
• MalfunctionMay 31, 2022Overheating of Device; Overheating of Device

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE DEVICES THAT WERE USED IN THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER THIS MFR. REPORT FOR THE FIRST FLEXIVA PULSE LASER FIBER, MFR REPORT # 3005099803-2022-02946 FOR THE SECOND FLEXIVA PULSE LASER FIBER & MFR REPORT # 3005099803-2022-02947 FOR THE THIRD FLEXIVA PULSE LASER FIBER. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT THREE FLEXIVA PULSE 242 LASER FIBERS WERE USED IN A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE FOR A STONE TREATMENT IN THE KIDNEY PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS P120 LASER CONSOLE. DURING THE PROCEDURE, WHEN THE PHYSICIAN PLUGGED IN EACH OF THE LASER FIBERS AND STARTED FIRING, THE DEVICE STARTED SMOKING. THE FIBER CONNECTOR WAS NOTED TO BE HOT TO THE TOUCH. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A FLEXIVA PULSE 365 LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14549836 ↗
• MalfunctionApr 18, 2022Break; Overheating of Device; Detachment of Device or Device Component; Break; Overheating of Device; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY AND URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS AN MOSES LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER CONNECTED TO THE LASER CONSOLE, A SMOKE WAS NOTICED AT THE CONNECTOR. UPON EXAMINATION, THE LASER FIBER WAS BROKEN ON THE BODY AND TIP. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT AND THERE WERE NO FIBER FRAGMENTS FELL INSIDE THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14136072 ↗
• MalfunctionJan 12, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE OF THE KIDNEY TO TREAT A KIDNEY STONE ON (B)(6) 2021. DURING THE PROCEDURE, THE FIBER BODY OVERHEATED AND BEGAN SMOKING AT THE END OF THE FIBER CONNECTOR. THE LASER FIBER WAS IMMEDIATELY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239523 ↗