Ureteral Catheter M0064002110Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729751663), received between Jun 9, 2017 and May 9, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 9, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2023. DURING THE PROCEDURE, THE CATHETER WAS BEING REMOVED FROM THE SCOPE; HOWEVER, THE CATHETER BROKE. THE PHYSICIAN REPORTED THAT NO UNORDINARY RESISTANCE WAS FELT AND THERE WAS NO ANY MISUSE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895861 ↗
• MalfunctionDec 8, 2022Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA 5F CONE TIP URETERAL CATHETER WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, WHEN THE DEVICE WAS IMPLANTED, IT WAS NOTICED THAT THE CONE TIP PORTION OF THE CATHETER WAS SHARP AND PIERCED THROUGH THE URETERAL ORIFICE. THE DEVICE WAS THEN REMOVED IMMEDIATELY, AND THE PROCEDURE WAS COMPLETED WITH AN OPEN-ENDED CATHETER. IT IS UNKNOWN HOW EXACTLY THE CATHETER PIERCED THE URETERAL ORIFICE. THERE WAS NO REPORTED TREATMENT PERFORMED FOR THE PATIENT INJURY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Perforation

  MAUDE report 15941269 ↗
• InjuryJun 28, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA UERETERAL CATHETER WAS USED IN THE URETERAL ORIFICE DURING A URETEROSCOPY PROCEDURE PERFORMED ON JUNE 3, 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN INSERTED THE DEVICE, HE NOTICED A LINEAR BURR ON THE CONE PORTION OF THE CATHETER WHICH CAUSED A CUT IN THE URETERAL ORIFICE OF THE PATIENT. REPORTEDLY, THE PATIENT EXPERIENCED BLEEDING AND THEY HAD TO PUT PRESSURE ON THE SITE TO STOP THE BLEEDING. AND THE PROCEDUE WAS COMPLETED AT THIS TIME. THE PATIENT WAS REPORTED TO HAVE FULLY RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Laceration(s)

  MAUDE report 12074907 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER DRAINAGE DEVICE WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER BROKE OFF AT THE END AND CREATED A BARBED SHARP TIP. REPORTEDLY, THE BROKEN CATHETER WAS REMOVED FROM THE SCOPE, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER DRAINAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. **ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2020** REPORTEDLY, THE TIP BROKE OFF DURING UNPACKING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11010942 ↗
• InjuryAug 29, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE BLADDER AND URETER DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE INSIDE THE PATIENT BUT WERE SUCCESSFULLY RETRIEVED, THOUGH IT IS UNKNOWN HOW THE PIECES WERE RETRIEVED. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE OKAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6827311 ↗
• InjuryJun 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA 5F CONE TIP URETERAL CATHETER WAS USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE URETER WAS PERFORATED WHEN ADVANCING THE FLEXIMA 5F CONE TIP URETERAL CATHETER. THE CONE TIP WAS NOTED TO BE TOO SHARP. IT IS UNKNOWN IF THERE WAS ADDITIONAL INTERVENTION PERFORMED FOR THE PUNCTURED URETER AND HOW THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Internal Organ Perforation

  MAUDE report 6629317 ↗