Ureteral Catheter M0064002010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729751571), received between May 16, 2017 and Jan 19, 2026 — classified as 7 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 17 most recent of 17 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionDec 5, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS UNPACKED FOR A LASER URETEROSCOPY PROCEDURE TO BE USED ON THE URETER ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PREPARATION, IT WAS NOTED THAT A HAIR WAS FOUND INSIDE THE PACKAGE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418947 ↗
• MalfunctionMar 21, 2019Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA URETERAL CATHETER BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA URETERAL CATHETER BALLOONS WERE UNPACKED FOR A PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THERE ARE TWO OPEN END URETERAL CATHETERS DEVICES IN WHICH THE SEAL ON THE PACKAGING WERE OPEN. REPORTEDLY, THE DEVICES WERE BAD AND UNABLE TO BE USED SINCE THEY WERE UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8441626 ↗
• MalfunctionMar 21, 2019Unsealed Device Packaging; Unsealed Device Packaging

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO FLEXIMA URETERAL CATHETER BALLOON USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO FLEXIMA URETERAL CATHETER BALLOONS WERE UNPACKED FOR A PROCEDURE ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THERE ARE TWO OPEN END URETERAL CATHETERS DEVICES IN WHICH THE SEAL ON THE PACKAGING WERE OPEN. REPORTEDLY, THE DEVICES WERE BAD AND UNABLE TO BE USED SINCE THEY WERE UNSTERILE. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8439436 ↗
• InjuryFeb 12, 2019Adverse 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 URETERAL CATHETER WAS USED IN THE URETER DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER IS TOO STIFF WHICH CAUSED A FALSE CRADLE LIKE INJURY TO THE PATIENT URETER. REPORTEDLY, A STENT WAS PLACED ON THE INJURY AND THE PROCEDURE WAS COMPLETED.

  Patient problems: Perforation

  MAUDE report 8330913 ↗
• MalfunctionOct 16, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AN EXTRA BUNCHED UP BALL SIMILAR TO THE CATHETER WAS FOUND AT THE TIP OF THE CYSTOSCOPE DURING INSERTION OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED DUE TO THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7969618 ↗
• MalfunctionAug 23, 2018Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS UNPACKED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING INSPECTION, A RED FOREIGN OBJECT WAS NOTICED. THERE WAS NO PROCEDURE AND PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 7809162 ↗
• MalfunctionNov 2, 2017Torn Material; Torn Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED DURING A RETROGADE PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING PROCEDURE, A BLUE EXTRA MATERIAL WAS FOUND AT THE TIP OF THE CATHETER DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER FLEXIMA URETERAL CATHETER ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6995856 ↗
• InjuryMay 16, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A FLEXIMA URETERAL CATHETER WAS USED IN THE URINARY BLADDER DURING A CYSTOSCOPY WITH RETROGRADE PYELOGRAM PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A PART OF THE CATHETER WAS BROKEN INTO PIECES AND WAS DISLODGED IN THE CATHETER. THE BROKEN PIECES WAS IRRIGATED OUT OF THE BLADDER. THERE WERE NO REPORTED COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6568867 ↗