Flexiva PulseRecalls & reported problems across all models

We found 5 models of Flexiva Pulse by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 41 adverse event reports in the FDA's MAUDE database, received between Dec 6, 2021 and Jan 16, 2026 — classified as 1 injury, 40 malfunctions.

The most frequently reported specific device problem is “Break” (23 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Flexiva Pulse recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2230-2023 · Root cause: Nonconforming Material/Component · Recall details · 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-2229-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. 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 Flexiva Pulse problems

Flexiva Pulse models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Flexiva Pulse M006L8405960

  Powered laser surgical instrument
  2 recalls9 reports
• Flexiva Pulse M006L8405910

  Powered laser surgical instrument
  1 recall12 reports
• Flexiva Pulse M006L8405920

  Powered laser surgical instrument
  16 reports
• Flexiva Pulse M006L8405930

  Powered laser surgical instrument
  3 reports
• Flexiva Pulse M006L8405940

  Powered laser surgical instrument
  1 report

Recent Flexiva Pulse adverse event reports

The 15 most recent reports across all models, 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 FIFTH FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24095338 ↗
• 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 ↗
• 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 ↗
• MalfunctionMay 1, 2025Gas Output Problem; Gas Output Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DEVICE HAD DECREASED IN LASER LIGHT AND VAPORIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT ANY PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FRACTURE WITHIN THE FIBER CONNECTOR; THEREFORE, THE REPORTABILITY CRITERIA IS MET BASED ON THIS INVESTIGATION FINDING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21940666 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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