UroPass 61238BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00821925035409), received between Mar 12, 2021 and Aug 29, 2023 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K051593); they may or may not involve this specific model.

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.

Recalls naming this device

1. Sep 11, 2024Open, Classified

   Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the package or in patients during surgical procedures.

   Z-0364-2025 · Root cause: Storage · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryAug 29, 2023Break; Break

  A COMPANY REPRESENTATIVE, ON BEHALF OF THE CUSTOMER, REPORTED THAT THE UROPASS BROKE IN THE PATIENT DURING AN UNSPECIFIED URINARY THERAPEUTIC PROCEDURE. THE TIP OF THE DILATOR BROKE OFF INSIDE THE URETER WHEN THE ACCESS SHEATH WAS INITIALLY INSERTED INTO THE URETER. THE SURGEON DIDN¿T KNOW THAT THE TIP BROKE OFF UNTIL THEY LASERED THE STONE. THE SURGEON ACCIDENTALLY LASERED THE BROKEN TIP OF THE ACCESS SHEATH AND THAT¿S WHEN THEY DISCOVERED THE TIP HAD BROKEN OFF. A FLEXIBLE URETEROSCOPE WAS INSIDE THE SHEATH WHEN THE BROKEN TIP WAS DISCOVERED. ADDITIONALLY, A GUIDEWIRE WAS INSIDE THE SHEATH WHEN THE TIP BROKE. NO ERROR MESSAGES SHOWED UP, AS THE DEVICE IS DISPOSABLE. THE PROCEDURE WAS PROLONGED (BY AN UNKNOWN AMOUNT OF TIME) BECAUSE THEY HAD TO OPEN A STONE BASKET TO PULL OUT THE TIP OF THE SHEATH. THE TIP WAS CUT WITH THE LASER FIBER SO IT COULD BE SAFELY REMOVED FROM THE PATIENT WITHOUT DAMAGING THE URETER. THE PROCEDURAL OUTCOME WAS UNKNOWN. THE PATIENT CONDITION WAS NOT IMPACTED, AND NO ADDITIONAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643120 ↗
• MalfunctionAug 4, 2023Break; Break

  AN OLYMPUS SALES REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE FOR THE SUBJECT DEVICE ON BEHALF OF THE CUSTOMER. THE SHEATH (NOT THE FUNNEL PART) BROKE INSIDE THE PACKAGE. IT WAS REPORTED THE DEVICE FAILED UPON INITIAL USE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461809 ↗
• MalfunctionAug 4, 2023Break; Break

  AN OLYMPUS SALES REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE FOR THE SUBJECT DEVICE ON BEHALF OF THE CUSTOMER. THE SHEATH (NOT THE FUNNEL PART) BROKE INSIDE THE PACKAGE. IT WAS REPORTED THE DEVICE FAILED UPON INITIAL USE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17461507 ↗
• MalfunctionApr 18, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THE DEVICE DILATOR WAS FOUND BENT. THE ISSUE WAS FOUND DURING PREPARATION FOR USE. THE DEVICE WAS REPLACED AND THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16766248 ↗
• InjuryDec 28, 2022Material Separation; Material Separation

  (B)(6) MODEL# 61154BX / LOT # 09J1800111.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061820 ↗
• MalfunctionDec 8, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING A CYSTO-URETEROSCOPY PROCEDURE USING A UROPASS URETERAL ACCESS SHEATH DILATOR, THE SHEATH TIP BROKE OFF INSIDE THE PATIENT¿S BLADDER WHEN THE PHYSICIAN WAS ATTEMPTING TO ADVANCE IT OVER THE WIRE INTO THE URETER. THE DEVICE FRAGMENTS WERE RETRIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THIS OCCURRENCE. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE". THERE WERE NO PROCEDURAL OR ANATOMICAL CHALLENGES THAT COULD HAVE CONTRIBUTED TO THE DEVICE BREAKING. THE CUSTOMER EXAMINED A LIKE DEVICE STILL SEALED IN THE PACKAGE. AFTER TRYING TO WIGGLE THE DEVICE INSIDE THE PACKAGE, THE DEVICE SNAPPED INSIDE THE PACKAGE. ADDITIONAL COMMENT BY PHYSICIAN "ADDITIONAL DEVICES WERE CHECKED WHILE IN THE PACKAGING/UNOPENED AND SHOWED SAME DEFECT." ONE IMAGE WAS PROVIDED SHOWING A DEVICE BROKEN IN THE PACKAGE. CLARIFYING INFORMATION HAS BEEN REQUESTED, AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE CUSTOMER STORES THE DEVICES IN STERILE CORE HANGING UP THE WAY THEY ARE DESIGNED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE PATIENT EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DEVICE BROKEN IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941611 ↗
• MalfunctionMay 27, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED TO OLYMPUS, THE FIRST INSERTION OF THE URPOASS 12/14FR, 38CM WAS SUCCESSFUL. THE FLEXIBLE URF GOES VIA THE UROPASS TO SUCCESSFULLY REACH THE RENAL STONE AND CONDUCT STONE LASER LITHOTRIPSY. HOWEVER; UROLOGISTS FOUND IT DIFFICULT TO IN RE-INSERT THE URPOASS INTO THE PATIENT DURING THE MIDDLE OF A THERAPEUTIC A RETROGRADE INTRARENAL SURGERY (RIRS) PROCEDURE. THE INNER SHEATH OF THE UROPASS HAD BROKEN INTO PIECES. THE PROCEDURE WAS DELAYED FOR APPROXIMATELY 15 MINUTES AS THE PHYSICIAN RETRIEVED THE PIECES FROM THE PATIENT¿S URETER AND BLADDER, USING GRASPING FORCEPS. THE PATIENT WAS UNDER GENERAL ANESTHESIA AT THE TIME OF THE EVENT. THE PROCEDURE WAS COMPLETED USING ANOTHER 61238BX UROPASS. ACCORDING TO THE CUSTOMER, AN X-RAY IS ROUTINELY USED FOR THIS TYPE OF PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526934 ↗
• InjuryJan 20, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING A LASER URETEROSCOPIC STONE REMOVAL PROCEDURE USING A UROPASS ACCESS SHEATH, THE SHEATH TIP BROKE OFF INTO THE PATIENT. THE TIP WAS RETRIEVED AND PROCEDURE WAS COMPLETED WITH NO FURTHER CONSEQUENCES TO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND REPORTED EVENT WERE REQUESTED. THE CUSTOMER WAS UNABLE TO PROVIDE THE REQUESTED INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 13308711 ↗
• MalfunctionApr 20, 2021Material Separation; Material Separation

  IT WAS REPORTED, THE OLYMPUS UROPASS'S TIP SEPARATED WHILE IN USE. ACCORDING TO THE INITIAL REPORTER, THE SURGEON ATTEMPTED TO RETRIEVE ALL THE BROKEN PIECES. THE SCRUB NURSE DID MANAGED TO RETRIEVE SOME SEGMENTS. HOWEVER, AFTER GOING TO THE BATHROOM, THE PATIENT NOTED SOME 'WHITE REMNANTS' THAT WERE POSSIBLY FROM THE URETERAL ACCESS SHEATH. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11692793 ↗
• InjuryMar 12, 2021Material Separation; Material Separation

  IT IS REPORTED DURING A CYSTOSCOPY, LEFT URETEROSCOPY AND LEFT URETERAL STENT PLACEMENT, THE TIP OF THE URETERAL STENT BROKE OFF AND WAS RETAINED INSIDE THE PATIENT'S LEFT KIDNEY. REPORTED SEQUENCE OF EVENTS AS FOLLOWS: (B)(6) 2021: A 0.038 GUIDEWIRE WAS PLACED UP THE LEFT URETERAL ORIFICE AND PASSED UNDER FLUOROSCOPY INTO THE COLLECTING SYSTEM. A SEMI RIGID URETERAL SCOPE WAS THEN CAREFULLY PLACED OVER THE WIRE AND PASSED THROUGH THE URETERAL ORIFICE WITHIN THE MILD RESISTANCE. IT WAS PASSED CAREFULLY UNTIL THE CROSSING OF THE ILIACS WAS VISUALIZED, THE SCOPE WOULD NOT EASILY PASS THROUGH THIS AREA SO IT WAS REMOVED. THE FLEXIBLE SCOPE WAS THEN ASSEMBLED, A 12/14 URETERAL ACCESS SHEATH TROCAR WAS PASSED OVER THE WIRE AND ONLY MADE IT UP TO THE LEVEL OF THE ILIACS. NEXT, A NOTTINGHAM DILATOR WAS PASSED THROUGH THIS AREA AND WAS REMOVED. THE TROCAR FROM THE ACCESS SHEATH WAS PASSED ONCE AGAIN, BUT BEFORE PUTTING IT IN SITU IT WAS NOTICED THAT THE TIP OF IT WAS BROKEN OFF AND THE PLASTIC WAS SPLIT ON THE END OF THE TROCAR. THE PHYSICIAN WAS UNABLE TO LOCATE THE TIP OF THE TROCAR WHERE IT WAS BROKEN OFF. THE FLEXIBLE URETEROSCOPE WAS THEN PASSED OVER THE WIRE AND UP THE LEFT URETER. A

  Patient problems: Foreign Body In Patient

  MAUDE report 11477531 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K051593. One submission often covers many models, so check the product and lot details in each record.

• Z-2401-2023 · May 19, 2023 · Open, Classified
  UroPass Ureteral Access Sheaths, 5 pieces/box