Flexiva Pulse ID M006L8406940Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 08714729978701), received between Jun 15, 2023 and Jun 1, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026

  FROM OPERATIVE REPORT: FIRST ATTEMPTED TO PERFORM LITHOTRIPSY USING THE TRILOGY DEVICE AT THE HIGHEST SETTING BUT THIS WAS MAKING VERY LITTLE IMPACT ON THE STONE DUE TO ITS VERY HIGH DENSITY. THE DECISION WAS THEN MADE TO USE A 1000 MICRON HOLMIUM LASER FIBER FOR LITHOTRIPSY INSTEAD. LITHOTRIPSY WAS THEN BEGUN USING A POWER OF 100 W. HOWEVER, AFTER ABOUT 15 MINUTES OF LITHOTRIPSY THE FIBER BROKE DUE TO THE HIGH POWER. A NEW FIBER WAS THEN PLACED AND USING A SLIGHTLY LOWER POWER OF 75 W LITHOTRIPSY WAS CONTINUED. AFTER LITHOTRIPSY WAS COMPLETED ON ONE OF THE LARGE STONES, OPERATIVE TIME WAS APPROACHING 3 HOURS AND THE DECISION WAS MADE TO STOP HERE FOR THE DAY. THE TRILOGY WAS THEN REINSERTED AND USED TO CLEAR THE REMAINING DUST AND FRAGMENTS. THE NEPHROSCOPE WAS THEN REMOVED. A 22 FRENCH COUNCIL TIP FOLEY CATHETER WAS THEN INSERTED THROUGH THE ACCESS SHEATH INTO THE POUCH AND THE BALLOON INFLATED WITH 10 ML OF STERILE WATER. THE ACCESS SHEATH WAS THEN CUT SO IT COULD BE REMOVED OVER THE CATHETER. CONTRAST AND SALINE WERE THEN INJECTED THROUGH THE CATHETER INTO THE POUCH TO CONFIRM PLACEMENT. ALL WIRES WERE THEN REMOVED. THE SUPRAPUBIC TUBE WAS SECURED USING A 2-0 NYLON DRAIN STITCH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25347558 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE LASER FIBER BROKE AT THE EXPOSED GLASS TIP. THE SAME EVENT OCCURRED WITH TWO FIBERS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS FOR THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882797 ↗
• MalfunctionDec 23, 2025Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE LASER FIBER BROKE AT THE EXPOSED GLASS TIP. THE SAME EVENT OCCURRED WITH TWO FIBERS. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882583 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP BROKE OFF IN THE MIDDLE OF THE CASE. A SECOND FIBER WAS USED BUT THE SAME PROBLEM WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS FOR THE SECOND FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106907 ↗
• MalfunctionJan 8, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP BROKE OFF IN THE MIDDLE OF THE CASE. A SECOND FIBER WAS USED BUT THE SAME PROBLEM WAS ENCOUNTERED. THE PROCEDURE WAS COMPLETED WITH A THIRD FIBER DEVICE. THERE WERE NO PATIENT COMPLICATIONS. THIS EVENT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106901 ↗
• MalfunctionDec 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A URETEROSCOPY PROCEDURE TO TREAT A KIDNEY STONE, THE FIBER BROKE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043472 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN AFTER A SHORT AMOUNT OF TIME LASING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER AND NO PATIENT COMPLICATIONS REPORTED. THIS IS THE SECOND THE TWO COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19988661 ↗
• MalfunctionAug 5, 2024Break; Power Problem; Break; Power Problem

  IT WAS REPORTED THAT DURING A CYSTOLITHOPAXY PROCEDURE, THE GLASS TIP OF THE FIBER BROKE AND STOPPED WORKING. THE FIBER TIP WAS FLUSHED OUT FROM THE PATIENT BY USING AN ELLICK DEVICE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19913179 ↗
• MalfunctionAug 5, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER TIP WAS BROKEN AFTER A SHORT AMOUNT OF TIME LASING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19908525 ↗
• MalfunctionJul 23, 2024Break; Break

  IT WAS REPORTED THAT THE LASER WIRE CAME APART FROM THE FIBER CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE AND NO PATIENT COMPLICATIONS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19811234 ↗
• MalfunctionJun 10, 2024Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE FIBER WAS NOT RECOGNIZED BY THE LASER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. 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 19506021 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE TIP OF THE FIBER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER WITH NO PATIENT COMPLICATOINS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373022 ↗
• MalfunctionMay 22, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, THE FIBER TIP BROKE. A NEW FIBER WAS USED TO COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS. THIS REPORT IS FOR THE FIRST FIBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373015 ↗
• MalfunctionJun 20, 2023Break; Break

  IT WAS REPORTED THAT THE LASER FIBER TIP DEGRADED AFTER LESS THAN 1 MINUTE PEDAL TIME, AND THE TIP WAS ALSO BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17167779 ↗
• MalfunctionJun 15, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A LITHOPAXEY PROCEDURE FOR BLADDER STONE, AFTER 10 MINUTES OF LASING, THE FIBER TIP BURNED BACK TO THE CLADDING. IT WAS NEEDED TO USE ANOTHER FIBER TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139749 ↗