Flexiva Pulse ID M006L8406910Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729978671), received between Oct 14, 2021 and Sep 16, 2026 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. 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-2231-2023 · 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-2232-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50793193 ↗
• MalfunctionMay 11, 2026Communication or Transmission Problem

  IT WAS REPORTED THAT, DURING PREPARATION OF A URETEROSCOPY PROCEDURE WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA, WHEN THE FIBER WAS CONNECTED TO THE CONSOLE, AN ERROR APPEARED INDICATING ERROR 66 (PLEASE USE AUTHORIZED FIBER). AN ANOTHER FIBER WAS TRIED, HOWEVER NEITHER WERE COMPATIBLE WITH THE CONSOLE. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER ANESTHESIA OR SEDATION UNKNOWN. THIS COMPLAINT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25143100 ↗
• MalfunctionApr 30, 2026Break

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, IT WAS INDICATED THAT THE DEVICE WAS BROKEN/FRACTURED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25050526 ↗
• MalfunctionApr 28, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT PRIOR TO PROCEDURE, THE FIBER TIP WAS BROKEN OFF UPON OPENING FROM STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED A FIBER BODY BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020827 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE APPROXIMATELY FOUR CENTIMETERS FROM THE DISTAL END. 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 24891619 ↗
• InjuryFeb 27, 2026Break; Thermal Decomposition of Device

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE TIP OF THE FIBER BURNED OUT DURING ACTIVATION, AND THE TIP SEPARATED FROM THE FIBER. THE TIP REMAINED INSIDE THE PATIENT. THE DISCONNECTED TIP WAS IRRIGATED OUT OF THE PATIENT WITH SALINE. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24474518 ↗
• MalfunctionFeb 9, 2026

  DURING URETEROSCOPY, THE TIP OF THE LASER FIBER BURNED OUT DURING ACTIVATION, AND THE TIP SEPARATED FROM THE FIBER AND REMAINED INSIDE THE PATIENT. THE DISCONNECTED TIP WAS IRRIGATED OUT OF THE PATIENT WITH SALINE. MANUFACTURER RESPONSE FOR POWERED LASER SURGICAL INSTRUMENT, FLEXIVA PULSE ID (PER SITE REPORTER).

  Patient problems: Insufficient Information

  MAUDE report 24291104 ↗
• MalfunctionJan 14, 2026Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER TIP BROKE OFF INSIDE THE PATIENT AND WAS RETRIEVED USING A BASKET. 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 24069323 ↗
• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT THE FIBER BROKE DURING THE URETEROSCOPY PROCEDURE. ANOTHER FIBER WAS OPENED, BUT IT ALSO BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS REPORT IS FOR THE SECOND BROKEN FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23416470 ↗
• MalfunctionAug 11, 2025Break; Break

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE, THE FIBER TIP 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 22779392 ↗
• MalfunctionApr 17, 2025Break; Break

  IT WAS REPORTED THAT DURING A LASER LITHOTRIPSY PROCEDURE TO TREAT KIDNEY STONES, THE END OF THE FIBER THAT SCREWS INTO THE CONSOLE BROKE OFF WHEN THEY WERE TRYING TO CONNECT THE FIBER TO THE CONSOLE. THIS OCCURRED WHEN THEY WERE STARTING THE LITHOTRIPSY PORTION OF THE PROCEDURE. THE FIBER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED USING A SECOND FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21858199 ↗
• InjuryFeb 18, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PLASTIC TIP OF THE FIBER CAME OFF INSIDE THE PATIENT WHEN THE LASER TRIED TO BREAK THE STONE. IT WAS NOTED THAT THE BROKEN PLASTIC TIP WAS FOUND AND REMOVED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PATIENT AND PROCEDURE OUTCOME TO DATE, DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394857 ↗
• MalfunctionJan 10, 2025Overheating of Device; Use of Device Problem; Overheating of Device; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE ENERGY WOULD NOT COME OUT OF THE FIBER. THE CONNECTOR THAT PLUGS INTO THE LASER MELTED AND SMOKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125113 ↗
• MalfunctionNov 21, 2023Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT, DURING A PERCUTANEOUS NEPHROSTOLITHOTOMY PROCEDURE, SMOKE EMANATED FROM THE AREA WHERE THE LASER WAS CONNECTED TO THE MACHINE. IT WAS NOTED THAT THE SMOKE WAS FROM FIBER OVERHEATING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18185736 ↗
• MalfunctionAug 23, 2023Melted; Overheating of Device; Adverse Event Without Identified Device or Use Problem; Melted; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS FIBER MELTED CLOSE TO THE SUB MINIATURE A (SMA) CONNECTOR. IT WAS NOTED THAT THE FIBER BEING MELTED WAS IDENTIFIED BEFORE USING IT WITH THE PATIENT. THE FIBER WAS CHANGED, AND THE PROCEDURE WAS COMPLETED WITH A NEW FIBER WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17608528 ↗
• MalfunctionAug 18, 2023Break; Break

  IT WAS REPORTED THAT AT THE BEGINNING OF A URETEROSCOPY PROCEDURE FOR KIDNEY STONES, THE FIBER WAS FRACTURED AND BURNED BEHIND THE SUB MINIATURE A CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER AND NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17574500 ↗
• MalfunctionJul 5, 2023Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY FOR STONES, THE LASER FIBER WAS FRAYING. A BREAK WAS NOTICED ON THE TIP OF THE FIBER. THE PROCEDURE WAS COMPLETED USING A BASKET/STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262460 ↗
• MalfunctionJun 26, 2023Overheating of Device; Adverse Event Without Identified Device or Use Problem; Overheating of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A URETEROSCOPY WITH STENT REPLACEMENT FOR KIDNEY STONES TREATMENT, THE STAFF NOTICED A SMELL LIKE BURNING RUBBER. THE FIBER WAS DISCONNECTED AND REPLACED WITH A NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199677 ↗
• InjuryJul 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES THAT WERE USED IN THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JULY 5, 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE BLADDER, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS PULSE 100 H LASER CONSOLE WITH LASER SETTINGS OF 0.6 JOULES, 6 HERTZ AND 4 WATTS. ON (B)(6) 2022, FIVE DAYS POST PROCEDURE, THE PATIENT EXPERIENCED CYSTITIS. SHE WAS TREATED WITH CEPHALEXIN ORAL FOR INFECTION AND PROCHLOREPERAZINE IV FOR NAUSEA AND THE PATIENT'S CONDITION WAS RESOLVED.

  Patient problems: Urinary Tract Infection

  MAUDE report 15103743 ↗
• MalfunctionJul 26, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON JUNE 30, 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED DURING A PROCEDURE, PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASER FIBER PRODUCED SMOKE WHEN IT WAS ATTACHED INTO THE LASER CONSOLE. 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 15103269 ↗
• MalfunctionJun 22, 2022Connection Problem; Connection Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 31, 2022 THAT A FLEXIVA PULSE ID 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 PREPARATION, THE LASER FIBER WAS NOT RECOGNIZED BY THE LASER CONSOLE. THE PROCEDURE WAS UNABLE TO BE COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14779536 ↗
• MalfunctionJun 3, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 9, 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED IN PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, THE LASE FIBER BROKE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14592477 ↗
• MalfunctionMay 20, 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 ID LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE TO TREAT STONES IN THE LEFT KIDNEY UPPER AND LOWER POLE, PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A LUMENIS PULSE 120H LASER CONSOLE WITH MOSES WITH LASER SETTINGS OF 0.5 JOULES, PULSE FREQUENCY OF 80 HERTZ AND TOTAL LASER ENERGY OF 40 WATTS. DURING THE PROCEDURE, THE TIP OF THE LASER FIBER WAS DETACHED. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL FLEXIVA PULSE ID LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14461753 ↗
• MalfunctionMar 22, 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 ID LASER FIBER WAS USED IN A PROCEDURE IN THE URETER AND KIDNEY PERFORMED ON (B)(6) 2022. DURING PREPARATION, THE LASER FIBER TIP BROKE OFF OF THE LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13846903 ↗
• InjuryJan 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIVA PULSE LASER FIBER WAS USED DURING A LITHOTRIPSY PROCEDURE OF THE UPPER POLE OF THE RIGHT KIDNEY, PERFORMED ON (B)(6) 2021, AS PART OF THE U0703 FLEXIVA PULSE REGISTRY CLINICAL TRIAL. THE PROCEDURE WAS COMPLETED WITH THE FLEXIVA PULSE LASER FIBER. PRIOR TO DISCHARGE, THE PATIENT EXPERIENCED SEPSIS THAT WAS PROBABLY RELATED TO THE FLEXIVA PULSE LASER FIBER AND HAD A CAUSAL RELATIONSHIP TO THE LITHOTRIPSY PROCEDURE. THE SEPSIS WAS CONSIDERED LIFE THREATENING, ADDITIONAL INTERVENTION WAS REQUIRED AND THE PATIENT WAS HOSPITALIZED AND CATHETERIZED. THE SEPSIS WAS TREATED WITH MEDICATION: MAXIPIME, NORMAL SALINE, VANCOCIN, TYLENOL, AMIKIN, TRIMPEX, BENADRYL, TORADOL, ZOFRAN, LEVAQUIN, EPHEDRINE, CEFTIN. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2021, THE PATIENT WAS CATHETERIZED FROM (B)(6) 2021, AND THE SEPSIS WAS RESOLVED. ON (B)(6) 2021, THE PATIENT EXPERIENCED BLADDER SPASMS THAT WAS NON-SERIOUS, POSSIBLY RELATED TO THE FLEXIVA PULSE LASER FIBER AND PROBABLY RELATED TO THE LITHOTRIPSY PROCEDURE. THE BLADDER SPASMS WERE TREATED WITH MEDICATION: TOVIAZ, GLYCOPYRROLATE/NEOSTIGMINE, TORADOL, PYRIDIUM, DITROPAN. THE BLADDER SPA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Sepsis

  MAUDE report 13191005 ↗