NA M0064051000Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 08714729012689), received between Jul 30, 2019 and Jan 22, 2026 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A DUAL LUMEN URETERAL CATHETER DEVICE WAS SET TO BE USED DURING A URETEROSCOPY (URS) PROCEDURE. PRIOR TO PROCEDURE, IT WAS FOUND THAT THERE WAS A HAIR IN THE SEALED PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24153580 ↗
• MalfunctionJul 21, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT A DUAL LUMEN URETERAL CATHETER DEVICE WAS ABOUT TO BE USED DURING A PROCEDURE. REPORTEDLY, A HAIR WAS FOUND INSIDE OF 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 22561674 ↗
• InjuryJun 17, 2025Human-Device Interface Problem; Human-Device Interface Problem

  IT WAS REPORTED THAT A DUAL LUMEN URETERAL CATHETER DEVICE WAS USED DURING A URETEROSCOPY PROCEDURE. DURING THE PROCEDURE, A LEFT URETERAL INJURY OCCURRED FROM THE SHARP TIP DEVICE WHEN ATTEMPTING TO ACCESS THE URETER, AND A NON-BOSTON SCIENTIFIC DEVICE WAS USED TO COMPLETE ACCESS TO THE URETER. DUE TO THE URETERAL INJURY, THE LASING WAS NOT PERFORMED, AND INSTEAD, A URETERAL STENT WAS PLACED. THE PATIENT WILL BE EVALUATED AGAIN FOR URETERAL STRICTURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22235639 ↗
• MalfunctionFeb 18, 2025Break; Break

  IT WAS REPORTED THAT TWO DUAL LUMEN URETERAL CATHETER WERE USED DURING A URETEROSCOPY PROCEDURE. DURING INSERTION, THE SURGEON NOTICED SOME DAMAGE TO THE OUTSIDE OF IT WHERE SOME OF THE MAIN SHAFT HAD SPLIT AND WAS STICKING UP. ADDITIONALLY, A SECOND DUAL LUMEN CATHETER WAS INSERTED, AND THE SURGEON NOTICED THE CATHETER SPLIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE FIRST OF TWO DUAL LUMEN URETERAL CATHETER DEVICES USED IN THE SAME PATIENT AND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21395930 ↗
• MalfunctionFeb 18, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TWO DUAL LUMEN URETERAL CATHETER WERE USED DURING A URETEROSCOPY PROCEDURE. DURING INSERTION, THE SURGEON NOTICED SOME DAMAGE TO THE OUTSIDE OF IT WHERE SOME OF THE MAIN SHAFT HAD SPLIT AND WAS STICKING UP. ADDITIONALLY, A SECOND DUAL LUMEN CATHETER WAS INSERTED, AND THE SURGEON NOTICED THE CATHETER SPLIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS. THIS REPORT PERTAINS TO THE SECOND OF TWO DUAL LUMEN URETERAL CATHETER DEVICES USED IN THE SAME PATIENT AND PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21394414 ↗
• MalfunctionDec 11, 2023Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS ABOUT TO BE USED IN THE RIGHT URETER DURING A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE PERFORMED ON (B)(6) 2023. DURING PREPARATION, THE END OF THE URETERAL CATHETER WAS SEPARATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DUAL LUMEN URETERAL CATHETER. 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 GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18305680 ↗
• MalfunctionFeb 16, 2023Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS USED IN THE RIGHT URETER/KIDNEY DURING A CYSTO URETEROSCOPY LASER LITHOTRIPSY PROCEDURE ON (B)(6) 2022. DURING PROCEDURE, WHEN CATHETER WAS REMOVED, THE GUIDEWIRE FRAYED, AND IT GOT STUCK INSIDE THE DUAL LUMEN CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW AMPLATZ SUPER STIFF. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS: TIP TORN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385282 ↗
• MalfunctionJan 25, 2023Material Twisted/Bent; Material Split, Cut or Torn; Material Twisted/Bent; Material Split, Cut or Torn

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS USED IN THE KIDNEY DURING A URINARY DIVERSION PROCEDURE PERFORMED ON (B)(6) 2022. DURING UNPACKING, IT WAS NOTICED THAT THE TIP OF THE CATHETER LUMEN WAS BENT AND BROKEN. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO SUBMITTED BY THE CUSTOMER SHOWS THAT THE CATHETER WAS TORN AND BENT AT THE TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16242518 ↗
• MalfunctionSep 19, 2022Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS TO BE USED IN THE KIDNEY DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. DURING PREPARATION, AN EYELASH WAS NOTICED INSIDE THE DEVICE PACKAGING. THE PROCEDURE WAS COMPLETED WITH ANOTHER DUAL LUMEN URETERAL CATHETER. NOTE: A PHOTO WAS SUBMITTED BY THE CUSTOMER SHOWING AN EYELASH INSIDE THE DEVICE PACKAGING. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15447010 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NOTE: THIS REPORT PERTAINS TO A BOSTON SCIENTIFIC URETERAL CATHETER USED WITH A BOSTON SCIENTIFIC FIBER AND BASKET IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS ENROLLED INTO THE U0703 FLEXIVA PULSE REGISTRY STUDY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT UNDERWENT A LITHOTRIPSY PROCEDURE FOR STONE MANAGEMENT USING A FLEXIVA PULSE LASER FIBERS, A ZERO TIP BASKET, AND A DUAL LUMEN URETERAL CATHETER IN THE LEFT KIDNEY. DURING THE PROCEDURE, THE DEVICES WERE INTRODUCED INTO THE PATIENT WITHOUT PROBLEMS AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. ON (B)(6) 2022, THE PATIENT EXPERIENCED SYMPTOMS OF INFLAMMATION (PYELITIS) AND INFECTION (CYSTITIS) WITH NON SERIOUS SEVERITY. THE PATIENT WAS GIVEN A PERCOCET 5-325MG FOR THE PYELITIS AND A CEPHALEXIN 500MG FOR THE CYSTITIS. THE PYELITIS WAS CONSIDERED RESOLVED ON (B)(6) 2022 AND THE CYSTITIS WAS CONSIDERED RESOLVED ON (B)(6) 2022. IN THE PHYSICIANS ASSESSMENT, THERE IS NO RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE DUAL LUMEN URETERAL CATHETER AND A PROBABLE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE LITHOTRIPSY PROCEDURE. THERE WAS NO REPORTED MALFUNCTIO

  Patient problems: Inflammation; Urinary Tract Infection

  MAUDE report 15242485 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE CATHETER FELL APART. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON 05AUG2019 NOTE: THIS REPORT PERTAINS TO ONE OF TWO DUAL LUMEN URETERAL CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO DUAL LUMEN URETERAL CATHETERS WERE USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE Y-JUNCTION OF THE CATHETER BREAK APART AND BOTH OF THE TIPS FELL OFF. THE SAME ISSUE OCCURRED WITH THE SECOND DUAL LUMEN URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8841799 ↗
• MalfunctionJul 30, 2019Break; Break

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A DUAL LUMEN URETERAL CATHETER WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE CATHETER FELL APART. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION RECEIVED ON 05AUG2019. NOTE: THIS REPORT PERTAINS TO ONE OF TWO DUAL LUMEN URETERAL CATHETERS USED IN THE SAME PATIENT AND PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO DUAL LUMEN URETERAL CATHETERS WERE USED IN THE URETER DURING A URETEROSCOPY PROCEDURE PERFORMED ON (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE Y-JUNCTION OF THE CATHETER BREAK APART AND BOTH OF THE TIPS FELL OFF. THE SAME ISSUE OCCURRED WITH THE SECOND DUAL LUMEN URETERAL CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8840750 ↗