Flexiva Pulse ID M006L8406960Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729978718), received between Apr 18, 2022 and Apr 14, 2026 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (11 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-2234-2023 · 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-2233-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN IN THE RENAL CALYX. IT WAS NOTED THAT THE LASER TIP WAS REMOVED INTACT 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 24868061 ↗
• MalfunctionFeb 3, 2026Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER SNAPPED APPROXIMATELY TWO INCHES FROM THE TIP INSIDE THE SCOPE. 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 24247316 ↗
• MalfunctionOct 23, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE DISTAL END OF THE FIBER BROKE OFF IN THE PATIENT'S KIDNEY AND WAS IRRETRIEVABLE. THERE WAS NO REPORT OF PATIENT OR PROCEDURE OUTCOME.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23375433 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT WHEN THE DEVICE WAS OPENED, THE FIBER TIP WAS FOUND DISCONNECTED. THE PROCEDURE AS COMPLETED WITH ANOTHER OF THE SAME. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23086134 ↗
• InjurySep 16, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS MISSING, AND THE FRAGMENT WAS LOCATED INSIDE A CALYX OF THE KIDNEY. AN ATTEMPT WAS MADE TO RETRIEVE THE FRAGMENT USING A PIRANHA GRASPER, BUT IT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069120 ↗
• MalfunctionJun 25, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBERGLASS TIP WAS BROKEN. IT WAS NOTED THAT WHEN THE LASER WAS FIRST INITIATED, THERE WAS A POPPING NOISE, AND THE TIP CAME OFF WHERE THE GREEN MEETS THE CLEAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22331843 ↗
• MalfunctionMay 28, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER HAD LIGHT COMING THROUGH AND WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100539 ↗
• MalfunctionFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE FIBER WAS RETURNED WITHOUT INITIAL REPORTER AND PERFORMANCE ALLEGATION INFORMATION. ANALYSIS OF THE RETURNED DEVICE IDENTIFIED THAT THE FIBER WAS RECEIVED IN TWO PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21471692 ↗
• MalfunctionFeb 24, 2025Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER HAD NO ENERGY WHEN THE CONSOLE'S PEDAL WAS PUSHED. A SECOND FIBER WAS OPENED; HOWEVER, THE SAME PROBLEM WAS ENCOUNTERED. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELED PROCEDURE WITH A PATIENT UNDER GENERAL ANESTHESIA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21447022 ↗
• MalfunctionFeb 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE A PIECE OF THE FIBER TIP WAS FOUND INSIDE THE PATIENT'S KIDNEY. THE TIP WAS RETRIEVED AND INTACT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18669088 ↗
• MalfunctionSep 5, 2023Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A KIDNEY PROCEDURE TWO DIFFERENT FIBERS FAILED AS THE DISTAL TIP FRAYED/MELTED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE METHOD WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17686515 ↗
• MalfunctionJul 14, 2023Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT THE FIBER WOULD NOT DELIVER ENERGY DURING PROCEDURE. THE FIBER WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. UPON RECEIPT A FIBER BREAK WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324878 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A LITHOTRIPSY PROCEDURE, THE LASER FIBER BROKE. UPON REMOVAL OF THE FIBER FROM THE SCOPE, THE BROKEN FRAGMENT DROPPED INTO THE PATIENT'S BLADDER AND THEN WAS REMOVED. THERE WAS NO SUSPECTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17253114 ↗
• InjuryJun 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT UNDERWENT LITHOTRIPSY STUDY PROCEDURE ON RIGHT URETER FOR STONE TREATMENT. THE CONSOLE SETTING USED FOR THE PROCEDURE SHOWED PULSE LENGTH LONG, PULSE ENERGY 0.6J, PULSE FREQUENCY 6HZ AND TOTAL LASER ENERGY 3.6W. THE FIBER WAS NOT STRIPPED OR CLEAVED. THE FIBER WAS USED WITH STORZ FLEXIBLE SCOPE AND MOSES PULSE CONSOLE. THERE WERE NO OTHER ACCESSORY DEVICES INTRODUCED INTO THE PATIENT BODY DURING THE PROCEDURE. NO ADVERSE EVENTS WERE NOTED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. 6 X 26 FRENCH URETERAL STENT WAS PLACED ON THE PROCEDURE DAY AND REMOVED ON TWENTY DAYS POST PROCEDURE. THE PATIENT DISCHARGE MEDICATIONS INCLUDED TYLENOL FOR PAIN PROPHYLAXIS, BACTRIM DS FOR POSTOPERATIVE ANTIBIOTIC PROPHYLAXIS, FLOMAX FOR STONE REMOVAL, AND ZYLOPRIM FOR HISTORY OF URIC ACID STONES AND ELEVATED URIC ACID IN BLOOD. THE PATIENT BEGAN EXPERIENCING DYSURIA AND HEMATURIA FIFTY-ONE DAYS POST PROCEDURE. THE PATIENT SYMPTOMS WERE REPORTED TO BE NOT SERIOUS. MEDICATION (CIPROFLOXACIN) WAS PROVIDED TO THE PATIENT. THE PATIENT SYMPTOMS WERE REPORTED TO BE RESOLVED (DATE UNKNOWN). THE STUDY FACILITY ASSESSED THE PATIENT SYMPTOMS AS POSSIBLY RELATED TO THE

  Patient problems: Dysuria; Hematuria

  MAUDE report 17101345 ↗
• MalfunctionJun 21, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE LASER FIBER WAS BROKEN. 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 14754066 ↗
• MalfunctionJun 7, 2022Break; Overheating of Device; Misfire; Break; Overheating of Device; Misfire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON MAY 16, 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED IN A LASER URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. THE LASER UNIT USED WAS A VERSA PULSE 100 LASER CONSOLE. DURING THE PROCEDURE, THE LASER FIBER BROKE IN HALF. IT BURNED A SMALL HOLE IN THE PATIENT'S DRAPE AND WET TOWEL. THERE WAS NO BURN INJURY TO THE USER OR TO THE PATIENT. NO FIBER FRAGMENTS FELL INSIDE THE PATIENT. THE USER CONFIRMED THE PRESENCE OF THE HEAT FROM THE LASER CABLE DURING THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14620623 ↗
• MalfunctionJun 1, 2022Break; Temperature Problem

  DURING THE PROCEDURE WHILE THE SURGEON WAS USING THE LASER, THE FLEXIVA PULSE ID TRACTIP ("LASER FIBER") CONNECTED TO THE LASER UNIT BROKE IN HALF. WET TOWEL PLACED ON TOP OF THE PATIENT AND A THE PATIENT DRAPE HAD SMALL BURN HOLES. THE DROP WAS ON TOP OF A STIRRUP COVER, SO IT DID NOT TOUCH THE PATIENT. NEITHER THE PATIENT OR ANY MEMBER OF THE OPERATING ROOM TEAM WAS HARMED. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14574775 ↗
• MalfunctionApr 18, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS OPENED FOR USE ON (B)(6) 2022. DURING PREPARATION, THERE WAS A SMALL HOLE OBSERVED ON THE STERILE PACKAGING. 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 14136665 ↗