Flexiva Pulse ID M006L8406920Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 08714729978688), received between Apr 18, 2022 and May 12, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Overheating of Device

  IT WAS REPORTED THAT THE FIBER WAS CONNECTED TO THE LASER WHEN A SOUND WAS HEARD, AND THE TIP WAS FOUND TO BE BURNED. THE PRODUCT DID NOT COME INTO CONTACT WITH THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER FIBER. THERE WAS NO REPORT OF PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150968 ↗
• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE FIBER BROKE AND STOPPED WORKING. AN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24678210 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FIBER BROKE AS THE PHYSICIAN WAS ADVANCING IT INTO THE SCOPE. THE PROCEDURE WAS COMPLETE WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415309 ↗
• MalfunctionJan 27, 2026Break; Overheating of Device

  IT WAS REPORTED THAT, DURING THE URETEROSCOPY PROCEDURE TO TREAT KIDNEY STONES, THE FIBER BROKE AND KEPT ON FIRING BACK. IT WAS ALSO NOTED THAT THE FIBER WAS OVERHEATING. THE PROCEDURE WAS COMPLETED WITH A NEW FIBER. THERE WAS NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24190310 ↗
• InjuryNov 13, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE TOWARDS THE TIP AND FRAGMENTS FELL INSIDE THE PATIENT. IT WAS NOTED THAT THE FRAGMENTS WERE RETRIEVED USING A GRASPER. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23540946 ↗
• InjuryNov 12, 2025Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE FIBER BROKE TOWARDS THE TIP AND FRAGMENTS FELL INSIDE THE PATIENT. IT WAS NOTED THAT THE FRAGMENTS WERE RETRIEVED USING A GRASPER. 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 23539150 ↗
• MalfunctionMay 26, 2022Break; Failure to Fire; Break; Failure to Fire

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2022 THAT A FLEXIVA PULSE ID LASER FIBER WAS USED IN A URETEROSCOPY PROCEDURE FOR A STONE TREATMENT IN THE URETER PERFORMED ON (B)(6). DURING THE PROCEDURE, THE LASER FIBER DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIVA PULSE ID LASER FIBER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING OF LASER FIBER BROKEN WITHIN THE CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14514687 ↗
• 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 14136667 ↗