Flexiva Pulse M006L8405960Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08714729978619), received between Feb 28, 2022 and Jan 10, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

2 FDA recall records name this device's identifier, 2 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. How this data works · Data updated Oct 13, 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-2229-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

2. 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-2230-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

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 10, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS DAMAGED/SEPARATED WHILE INSIDE THE BODY. THE BROKEN SEGMENT WAS SPONTANEOUSLY EXCRETED AND DID NOT REQUIRE RETRIEVAL. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21123664 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE FIBER HAD A RING OMITTING AROUND BEFORE BALL TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT REFERS TO THE THIRD FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201229 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE FIBER HAD A RING OMITTING AROUND BEFORE BALL TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT REFERS TO THE FOURTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201099 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE FIBER HAD A RING OMITTING AROUND BEFORE BALL TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT REFERS TO THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201058 ↗
• MalfunctionSep 12, 2024Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE FIBER HAD A RING OMITTING AROUND BEFORE BALL TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT REFERS TO THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201035 ↗
• MalfunctionJul 10, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT WHEN THE FIBER WAS BEING CONNECTED TO THE LASER, THE FIBER DID NOT FIT WELL DUE TO THE GREEN SLEEVE ON THE LASER FIBER. A SECOND LASER FIBER WAS OPENED AND ATTEMPTED TO BE CONNECTED AS WELL, BUT THE SECOND FIBER ALSO DID NOT FIT. IT WAS NOTED THAT THE GREEN HANDLE WAS TOO LARGE. THE PATIENT HAD A STENT PLACED AND WILL COME BACK IN THE FUTURE FOR ANOTHER PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19716147 ↗
• MalfunctionJul 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 6, 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS BROKEN. THE PHYSICIAN CONTINUED TO USE THE LASER FIBER UNTIL THE TIP BURNED BACK FULLY AND OPENED A SECOND LASER FIBER. THE PROCEDURE WAS COMPLETED WITH THE SECOND FLEXIVA PULSE LASER FIBER. 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 15121345 ↗
• MalfunctionJun 8, 2022Overheating of Device; Material Integrity Problem; Overheating of Device; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A LASER LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE KIDNEY, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS 100 WATT LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER WAS CONNECTED TO THE LASER CONSOLE AND IT STARTED SMOKING. 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 14631652 ↗
• MalfunctionFeb 28, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON FEBRUARY 4, 2022 THAT A FLEXIVA PULSE TRACTIP LASER FIBER WAS USED IN A PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER BROKE OFF. 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 13624713 ↗