Flexiva Pulse M006L8405920Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08714729978589), received between Dec 6, 2021 and Jan 16, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 16 most recent of 16 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 FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095344 ↗
• 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 THIRD FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095340 ↗
• 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 FOURTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095334 ↗
• 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 SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095333 ↗
• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER MADE A POPPING NOISE AND THEN STOPPED FUNCTIONING. IT WAS ALSO NOTED THAT THE FIBER BODY 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 23888229 ↗
• MalfunctionDec 12, 2024Overheating of Device; Material Separation; Use of Device Problem; Overheating of Device; Material Separation; Use of Device Problem

  IT WAS REPORTED THAT, DURING A LASER LITHOTRIPSY PROCEDURE, THE FIBER WAS NOT PRODUCING ENOUGH ENERGY TO BREAK THE STONE. THE CONSOLE WAS TURNED OFF AND ON, AND THE FIBER WAS TRIED AGAIN. HOWEVER, THE FIBER WOULD NOT FIRE. WHEN THE FIBER WAS DISCONNECTED FORM THE CONSOLE, THE FIBER WAS FOUND TO BE WARM TO THE TOUCH. ADDITIONALLY, THE WIRE CONNECTION TO THE GREEN CONNECTOR APPEARED TO BE BOTH SEPARATED AND MELTED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20917825 ↗
• MalfunctionOct 16, 2024Break; Break

  IT WAS REPORTED THAT LASER FIBER SNAPPED INTO TWO PIECES. REPORTEDLY, NO PIECES WERE LEFT INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20467373 ↗
• MalfunctionMay 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE FIBER TIP WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER DEVICE AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19273759 ↗
• MalfunctionJan 26, 2024Overheating of Device; Optical Problem; Overheating of Device; Optical Problem

  IT WAS REPORTED THAT DURING INSERTION, THE DEVICE HAD TOO MUCH ENERGY GENERATED. THE SCREEN WAS ACTIVATED AND TURNED PURPLE ON THE SCOPE CAMERA. IT WAS MENTIONED THAT NO AIMING BEAM WAS SEEN, AND THE TIP WAS HARD TO DISTINGUISH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18592074 ↗
• MalfunctionJan 26, 2024Overheating of Device; Optical Problem; Overheating of Device; Optical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, UPON INSERTION, THE DEVICE HAD TOO MUCH ENERGY GENERATED. THE SCREEN WAS ACTIVATED AND TURNED PURPLE ON THE SCOPE CAMERA. IT WAS MENTIONED THAT NO AIMING BEAM WAS SEEN, AND THE TIP WAS HARD TO DISTINGUISH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18591303 ↗
• MalfunctionJun 30, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 10, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY, PERFORMED ON (B)(6), 2022. THE LASER UNIT USED WAS A LUMENIS VERSA PULSE LASER CONSOLE. DURING TO THE PROCEDURE, THE STAFF TOUCHED THE LASER FIBER CONNECTOR TO DISCONNECT AND WAS SURPRISED HOW HOT THE PIECE HAD BECOME. THE FIBER CONNECTOR WAS TOO HOT TO COMFORTABLY DISCONNECT WITH BARE SKIN TOUCHING THE PIECE. HAD TO WAIT UNTIL IT COOLED. THERE WAS NO BURN INJURY TO THE OPERATOR. 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 14874383 ↗
• MalfunctionJun 17, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 23, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A URETEROSCOPY PROCEDURE TO TREAT STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE PLASTIC PART OF THE LASER FIBER WAS NOTED TO BE HOT. THERE WAS NO REPORTED BURN INJURY TO THE USER OR TO THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14733789 ↗
• InjuryJun 15, 2022Detachment of Device or Device Component; 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 WITH LASER LITHOTRIPSY PROCEDURE TO TREAT URETERAL STONES IN THE URETER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A HOLMIUM LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FRAGMENT WITH A BASKET AND THOUGH IT WOULD PASS OUT NATURALLY. 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 14701905 ↗
• MalfunctionDec 6, 2021Break; Break

  NOTE: NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE FLEXIVA PULSE LASER FIBERS THAT WERE USED DURING THE SAME PROCEDURE. PLEASE REFER MANUFACTURER REPORT NUMBER 3005099803-2021-06327, MANUFACTURER REPORT NUMBER 3005099803-2021-06329 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA PULSE 365 LASER FIBERS WERE USED DURING A STONE PROCEDURE TO TREAT STONE DISEASE OF THE GALLBLADDER, PERFORMED ON (B)(6) 2021. A 20W HOLMIUM LASER CONSOLE WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, THE DISTAL END OF ALL THREE FLEXIVA PULSE 365 LASER FIBERS BROKE ABOUT 5MM BEYOND THE GLASS TIP. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. AFTER 3 ATTEMPTS WITH THE FLEXIVA PULSE 365 LASER FIBER IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 365 LASER FIBER. HOWEVER, IT WAS ALSO REPORTED THAT THE PROCEDURE WAS TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940902 ↗
• MalfunctionDec 6, 2021Break; Break

  THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE FLEXIVA PULSE LASER FIBERS THAT WERE USED DURING THE SAME PROCEDURE. PLEASE REFER MANUFACTURER REPORT NUMBER 3005099803-2021-06327, MANUFACTURER REPORT NUMBER 3005099803-2021-06328 AND THIS MANUFACTURER REPORT NUMBER FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA PULSE 365 LASER FIBERS WERE USED DURING A STONE PROCEDURE TO TREAT STONE DISEASE OF THE GALLBLADDER, PERFORMED ON (B)(6) 2021. A 20W HOLMIUM LASER CONSOLE WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, THE DISTAL END OF ALL THREE FLEXIVA PULSE 365 LASER FIBERS BROKE ABOUT 5MM BEYOND THE GLASS TIP. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. AFTER 3 ATTEMPTS WITH THE FLEXIVA PULSE 365 LASER FIBER IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 365 LASER FIBER. HOWEVER, IT WAS ALSO REPORTED THAT THE PROCEDURE WAS TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940851 ↗
• MalfunctionDec 6, 2021Break; Break

  NOTE: THIS MANUFACTURER REPORT PERTAINS TO ONE OF THREE FLEXIVA PULSE LASER FIBERS THAT WERE USED DURING THE SAME PROCEDURE. PLEASE REFER MANUFACTURER REPORT NUMBER 3005099803-2021-06328 AND MANUFACTURER REPORT NUMBER 3005099803-2021-06329 FOR THE ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE FLEXIVA PULSE 365 LASER FIBERS WERE USED DURING A STONE PROCEDURE TO TREAT STONE DISEASE OF THE GALLBLADDER, PERFORMED ON (B)(6) 2021. A 20W HOLMIUM LASER CONSOLE WAS USED DURING THE PROCEDURE. DURING THE PROCEDURE, THE DISTAL END OF ALL THREE FLEXIVA PULSE 365 LASER FIBERS BROKE ABOUT 5MM BEYOND THE GLASS TIP. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. AFTER 3 ATTEMPTS WITH THE FLEXIVA PULSE 365 LASER FIBER IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A FLEXIVA 365 LASER FIBER. HOWEVER, IT WAS ALSO REPORTED THAT THE PROCEDURE WAS TERMINATED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12940748 ↗