Flexiva Pulse M006L8405930Recalls & reported problems
Boston Scientific Corporation · High Power Single-Use Laser Fiber · Class 2
All models of Flexiva Pulse (5)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729978596), received between Dec 12, 2023 and May 1, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Gas Output Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionDec 14, 2023Break; Break
IT WAS REPORTED THAT DURING PREPARATION, THE FLEXIVA PULSE FIBERS WOULD NOT FIT THROUGH THE WOLF NEPHROSCOPE. IT WAS NOTED THAT THE FIBER WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NON-BSC FIBER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18328867 ↗MalfunctionDec 12, 2023Break; Break
IT WAS REPORTED THAT DURING PREPARATION, THE FLEXIVA PULSE FIBERS WOULD NOT FIT THROUGH THE WOLF NEPHROSCOPE. IT WAS NOTED THAT THE FIBER WAS BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER NON-BSC FIBER DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18315380 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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