Open End Ureteral Axxcess Catheter M0064001160Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 08714729751557), received between Jun 9, 2017 and Oct 3, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (14 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 3, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A URETERAL AXXCESS CATHETER DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE CATHETER HAD A CUT MAKING IT DIFFICULT TO INSERT AND HANDLE THE PRODUCT. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23209390 ↗
• MalfunctionOct 3, 2025Break; Nonstandard Device; Break; Nonstandard Device

  IT WAS REPORTED THAT A URETERAL AXXCESS CATHETER DEVICE WAS USED DURING A PROCEDURE. REPORTEDLY, THE URETERAL CATHETER BROKE. NO FURTHER INFORMATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23208747 ↗
• MalfunctionDec 8, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPEN END URETERAL AXXCESS CATHETER WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON NOVEMBER 20, 2023. DURING PREPARATION, UPON GETTING THE STERILE PRODUCT OUT OF ITS PEEL PACK, IT WAS NOTICED THAT IT WAS RIPPED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPEN END URETERAL AXXCESS CATHETER DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18293001 ↗
• MalfunctionJun 5, 2023Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPEN END URETERAL AXXCESS CATHETER DEVICE WAS USED IN THE BLADDER AND URETER DURING A CYSTOSCOPY WITH URETERIC STENT PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, IT WAS NOTICED THAT THE TIP OF THE CATHETER WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OPEN END URETERAL AXXCESS CATHETER. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS THE TIP OF THE CATHETER BREAK IN TWO PIECES. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058246 ↗
• MalfunctionFeb 3, 2022Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER OPEN END DEVICE WAS USED DURING A URETEROSCOPY (URS) PROCEDURE PERFORMED ON (B)(6)2022. DURING THE PROCEDURE, THE CATHETER BROKE INSIDE THE PATIENT. IT WAS REPORTED THAT A PIECE OF THE CATHETER WAS DETACHED INSIDE THE PATIENT; HOWEVER; IT IS UNKNOWN IF THE DETACHED PIECE HAS BEEN RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: THE PHOTOS SUBMITTED BY THE CUSTOMER CONFIRMED THAT THE CATHETER WAS BROKEN IN TWO SEPARATE PIECES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440274 ↗
• MalfunctionFeb 2, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER OPEN END DEVICE WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS FOUND THAT THE TIP OF THE CATHETER WAS TORN. THE PROCEDURE WAS COMPLETED WITH ANOTHER AXXCESS URETERAL CATHETER OPEN END DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13423439 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AXXCESS URETERAL CATHETER DEVICE WAS USED DURING A CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER WAS FOUND TO BE BROKEN AT THE END AFTER IT WAS WITHDRAWN FROM THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9529774 ↗
• MalfunctionDec 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A AXXCESS URETERAL CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, IT WAS NOTED THAT THEY WERE ABLE TO USE THE DEVICE; HOWEVER, UPON REMOVING THE CATHETER FROM THE PATIENT IT WAS NOTICED THAT THE TIP OF THE CATHETER BROKE OFF. REPORTEDLY, THERE WERE NO PART OF THE CATHETER LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED AT THIS TIME. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9418907 ↗
• InjuryJul 23, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER OPEN END WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING REMOVAL OF THE DEVICE, IT WAS NOTED THAT THE CATHETER WAS SLICED IN HALF. REPORTEDLY, PART OF THE DEVICE HAD DETACHED IN THE URETER OF THE PATIENT AND WAS RETRIEVED USING GRASPERS. THE PROCEDURE WAS COMPLETED AT THIS TIME. ADDITIONALLY, IT WAS SUSPECTED THAT THE PROBLEM IS DUE TO CUTTING THE DEVICE FROM THE SCOPE. 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 8817265 ↗
• MalfunctionApr 25, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER OPEN END WAS USED IN THE BLADDER DURING A CYSTOSCOPY AND URETERAL STENTING PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER OF THE DEVICE SNAPPED INSIDE THE BLADDER WHILE INTRODUCING THROUGH THE CYSTOSCOPE. REPORTEDLY, THE PROCEDURE WAS COMPLETED WITH AN UNKNOWN DEVICE. 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 STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8548971 ↗
• InjuryApr 9, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER OPEN END WAS USED IN THE URINARY TRACT DURING A URETERAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6), 2019. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AXXCESS URETERAL CATHETER WAS INSERTED USING THE OVER THE WIRE TECHNIQUE THROUGH A CYSTOSCOPE. THE WIRE AND THE URINE INSIDE THE RENAL PELVIS WAS REMOVED. IT WAS ALSO NOTED THAT THE CATHETER WAS ATTEMPTED TO REMOVED FROM THE PATIENT; HOWEVER, THE PHYSICIAN FELT FRICTION AND WAS UNAWARE THAT THE CATHETER WAS GETTING STRETCHED. THE PHYSICIAN THOUGHT THAT THE CATHETER WAS ALREADY ABLE TO BE REMOVED, SO HE ADDED MORE FORCE WHICH CAUSED THE CATHETER TO BREAK AND GOT SEPARATED. TREATMENT WAS UNABLE TO BE PERFORMED AND THE PROCEDURE WAS COMPLETED AS IT WAS. ON (B)(6) 2019, THE PATIENT WAS TRANSFERRED TO A DIFFERENT HOSPITAL AND A PLASTIC STENT WAS PLACED FROM THE SIDE OF THE DETACHED AXXCESS CATHETER TO TREAT STONE-INDUCED PYELONEPHRITIS AND AFTER THAT, THE PATIENT CONDITION SEEMS TO HAVE RECOVERED TO A STATE THAT NO ANTIBIOTICS ARE NEEDED. THE PATIENT WAS THEN SCHEDULED FOR A SURGERY ON (B)(6), TO REMOVE THE REMAINING STONES AND THE CATHETER T

  Patient problems: No Code Available

  MAUDE report 8496724 ↗
• MalfunctionApr 4, 2019Break; Break

  THIS REPORT PERTAINS TO ONE OF THREE AXXCESS URETERAL CATHETER OPEN END USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE AXXCESS URETERAL CATHETER OPEN END WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THREE URETERAL CATHETERS BROKE CONSEQUENTLY DURING THE PROCEDURE. REPORTEDLY, NO PIECE OF THE DEVICES DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483005 ↗
• MalfunctionApr 4, 2019Break; Break

  THIS REPORT PERTAINS TO ONE OF THREE AXXCESS URETERAL CATHETER OPEN END USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE AXXCESS URETERAL CATHETER OPEN END WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THREE URETERAL CATHETERS BROKE CONSEQUENTLY DURING THE PROCEDURE. REPORTEDLY, NO PIECE OF THE DEVICES DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8483004 ↗
• MalfunctionApr 4, 2019Break; Break

  NOTE: THIS REPORT PERTAINS TO ONE OF THREE AXXCESS URETERAL CATHETER OPEN END USED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THREE AXXCESS URETERAL CATHETER OPEN END WERE USED DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THREE URETERAL CATHETERS BROKE CONSEQUENTLY DURING THE PROCEDURE. REPORTEDLY, NO PIECE OF THE DEVICES DETACHED INSIDE THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8482973 ↗
• InjuryJan 16, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPEN END URETERAL AXXCESS CATHETER WAS USED IN THE URETER DURING A RETROGRADE UROGRAPHY PROCEDURE PERFORMED ON (B)(6) 2018 . ACCORDING TO THE COMPLAINANT, THE PHYSICIAN FOUND THAT THE CATHETER WAS BROKEN INSIDE THE PATIENT WHEN X-RAY WAS PERFORMED ON (B)(6) 2018, SUBSEQUENT TO THE RETROGRADE UROGRAPHY PROCEDURE PERFORMED ON (B)(6) 2018. REPORTEDLY, THE PATIENT UNDERWENT A PROCEDURE AND THE BROKEN CATHETER WAS SUCCESSFULLY REMOVED USING FORCEPS ON (B)(6) 2019.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8252804 ↗
• InjuryOct 31, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXXCESS URETERAL CATHETER WAS USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CATHETER BROKE INTO TWO PIECES INSIDE THE PATIENT BUT WERE SUCCESSFULLY RETRIEVED; HOWEVER, IT IS UNKNOWN HOW THE PIECES WERE RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AFTER THE PROCEDURE WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION RECEIVED ON NOVEMBER 07, 2017. THE PROCEDURE WAS CYSTO, RIGHT URETEROSCOPY, RETROGRADE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6991144 ↗
• MalfunctionJun 9, 2017Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN OPEN END URETERAL AXXCESS CATHETER WAS USED IN THE KIDNEY DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, THEY WERE WITHDRAWING THE CATHETER FROM THE PATIENT'S PENIS AND UPON PULLING THE CATHETER FROM THE PATIENT, THE CATHETER BROKE INTO TWO PIECES. THE CATHETER WAS SUCCESSFULLY PULLED OUT AND NOTED THAT THERE WERE NO FRAGMENTS OF THE CATHETER LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED 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 6629356 ↗