Ureteral CatheterRecalls & reported problems across all models

We found 4 models of Ureteral Catheter by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between May 16, 2017 and Jan 19, 2026 — classified as 10 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Ureteral Catheter problems

Ureteral Catheter models

4 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Ureteral Catheter M0064002010

  CATHETER, UROLOGICAL
  17 reports
• Ureteral Catheter M0064002110

  CATHETER, UROLOGICAL
  6 reports
• Ureteral Catheter M0064002120

  CATHETER, UROLOGICAL
  2 reports
• Ureteral Catheter M0064001530

  CATHETER, URETHRAL
  1 report

Recent Ureteral Catheter adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJan 19, 2026Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A FLEXIMA URETERAL CATHETER DEVICE WAS SET TO BE USE DURING A URETEROSCOPY (URS) PROCEDURE. REPORTEDLY, PRIOR TO THE PROCEDURE, A HAIR WAS NOTICED INSIDE THE PACKAGING BEFORE OPENING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108808 ↗
• InjuryOct 20, 2025Break; Break

  IT WAS REPORTED THAT A FLEXIMA OPEN END URETERAL CATHETER DEVICE WAS USED DURING A CYSTOSCOPY PROCEDURE. REPORTEDLY, THE URETERAL CATHETER BROKE INSIDE THE SCOPE INTO THREE PIECES. ALL THE BROKEN PIECES WERE RETRIEVED AND CONFIRMED DURING VISUAL INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337395 ↗
• MalfunctionDec 4, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A FLEXIMA URETERAL CATHETER DEVICE WAS TO BE USED ON A KIDNEY STONE REMOVAL PROCEDURE. DURING PREPARATION, IT WAS FOUND THAT ONE UNIT INSIDE THE BOX WAS OPEN OR WAS NOT PROPERLY SEALED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20848104 ↗
• MalfunctionNov 16, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA OPEN END URETERAL CATHETER DEVICE WAS ABOUT TO BE USED IN THE URETEROSCOPY (URS) PROCEDURE ON AN UNKNOWN DATE. PRIOR TO PROCEDURE, IT WAS FOUND THAT THE PRODUCT PACKAGING WAS TORN OR RIP, AND BECAUSE OF THAT THE PRODUCT WAS NO LONGER STERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA OPEN END URETERAL CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18155263 ↗
• MalfunctionAug 18, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A FLEXIMA 5F OPEN END URETERAL CATHETER WAS PREPARED FOR A FLEXIBLE URETEROSCOPY WITH LASER LITHOTRIPSY PROCEDURE IN THE URETER PERFORMED ON (B)(6), 2023. DURING PREPARATION, A BLACK SPECK WAS FOUND INSIDE THE PACKAGE BEFORE OPENING. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA 5F OPEN END URETERAL CATHETER. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS A BLACK SPECK INSIDE THE STERILE POUCH OF THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17571244 ↗
• 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 ↗
• InjuryMar 30, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA 5F OPEN END URETERAL CATHETERS WERE PLACED BILATERALLY IN THE KIDNEY DURING A LOW ANTERIOR RESECTION AND COLOSTOMY TAKEDOWN PROCEDURE PERFORMED ON (B)(6) 2021. ON (B)(6) 2021, THE CATHETERS WERE REMOVED AT THE BEDSIDE OF THE PATIENT. THE CATHETER ON THE LEFT KIDNEY WAS REMOVED WITHOUT PROBLEM; HOWEVER, THE RIGHT CATHETER FRACTURED, AND A 10-CENTIMETER PORTION OF THE CATHETER REMAINED IN THE URETER AND KIDNEY OF THE PATIENT. THE PATIENT HAD TO BE SENT TO THE OPERATING ROOM TWICE IN AN ATTEMPT TO RETRIEVE THE REMAINING FRAGMENT AND THE ENTIRE REMAINING PORTION OF THE CATHETER WAS SUCCESSFULLY REMOVED ON THE SECOND ATTEMPT. THE PATIENT HAD A NEPHROSTOMY TUBE PLACED WHICH REQUIRES ROUTINE NEPHROSTOMY TUBE CHANGES FOR THE REST OF HIS LIFE. THE PATIENT EXPERIENCED PAIN, INFECTION, DISCOMFORT AND PERFORATION WHICH WAS CONFIRMED WHEN EXTRAVASATION SEEN WHEN CONTRAST WENT INTO THE BLADDER DURING ATTEMPT TO RETRIEVE FRACTURED PIECE OF THE CATHETER. IT WAS REPORTED THAT THE PATIENT UNDERGONE DIAGNOSTIC TESTING DUE TO PAIN AND ALTERED LABS INCLUDED; ABDOMEN X-RAY, RENAL ULTRASOUND, COMPUTED TOMOGRAPHY (CT) SCAN IN THE ABDOMEN AND

  Patient problems: Discomfort; Extravasation; Pain; Perforation; Unspecified Infection

  MAUDE report 16642179 ↗
• 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 ↗
• InjurySep 24, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA OPEN END URETERAL CATHETER DEVICE WAS USED IN THE BLADDER DURING A CYSTOSCOPY STENT EXCHANGE PROCEDURE PERFORMED ON (B)(6) 2022. DURING THE PROCEDURE, A SCOPE WAS PLACED USING A SINGLE BRIDGE AND THE CATHETER WAS INSERTED ALONG WITH THE GUIDEWIRE. THE CATHETER WAS THEN PULLED BACK OUT LEAVING THE GUIDEWIRE AND A STENT WAS PLACED OVER THE WIRE; HOWEVER, A BROKEN PIECE OF THE BLUE OPEN END CATHETER CAME INTO VIEW WHILE INSERTING THE STENT. THE BROKEN PIECE WAS RETRIEVED; HOWEVER, A SECOND SMALL PIECE WAS NOTICED WHILE EMPTYING THE BLADDER AND WAS RETRIEVED. IT WAS REPORTED THAT AN X-RAY AND VISUAL INSPECTION USING SCOPE WERE PERFORMED WHICH CONFIRMED THAT NO REMAINING PIECES WERE LEFT INSIDE THE BLADDER AND ALL THE BROKEN PIECES OF THE CATHETER WERE SUCCESSFULLY RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15475223 ↗
• InjurySep 29, 2021Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER DRAINAGE WAS USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, WHEN THE PHYSICIAN WAS FINISHING THE CASE AND WAS PLACING THE STENT, THE STENT GOT STUCK IN THE URETHRAL ORIFICE. AN OPEN ENDED CATHETER WAS USED REMOVE THE STENT; HOWEVER, THE CATHETER GOT STUCK AND BROKE. A RETRIEVAL DEVICE WAS USED TO REMOVE THE BROKEN PIECE AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12545756 ↗
• MalfunctionJul 19, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE KIDNEY DURING A RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE BLADDER AND WAS UNDER DIRECT VISUALIZATION. IT WAS NOTICED THAT THE CATHETER HAS A BURR ON THE CONE PORTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188053 ↗
• MalfunctionJul 19, 2021Defective Device; Defective Device

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE KIDNEY DURING A RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, THE CATHETER WAS INSERTED INTO THE BLADDER AND WAS UNDER DIRECT VISUALIZATION. IT WAS NOTICED THAT THE CATHETER HAS A BURR ON THE CONE PORTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188047 ↗
• 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 ↗
• InjuryNov 17, 2020Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE BLADDER AND URETER DURING URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6)2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THE CATHETER WAS BROKEN INTO TWO PIECES WHILE PASSING THE DEVICE. REPORTEDLY, THE DEVICE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10850897 ↗

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