UroPassRecalls & reported problems across all models

We found 15 models of UroPass by Gyrus ACMI, LLC in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jan 7, 2021 and Nov 11, 2024 — classified as 25 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Break” (20 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

UroPass recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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 · names 15 of these models · Recall details · FDA record ↗

Most reported UroPass problems

UroPass models

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

• UroPass 61238BX

  ACCESSORIES, CATHETER, G-U
  1 recall10 reports
• UroPass 61024BX

  ACCESSORIES, CATHETER, G-U
  1 recall5 reports
• UroPass 61138BX

  ACCESSORIES, CATHETER, G-U
  1 recall5 reports
• UroPass 61046BX

  ACCESSORIES, CATHETER, G-U
  1 recall4 reports
• UroPass 61054BX

  ACCESSORIES, CATHETER, G-U
  1 recall4 reports
• UroPass 61146BX

  ACCESSORIES, CATHETER, G-U
  1 recall4 reports
• UroPass 61224BX

  ACCESSORIES, CATHETER, G-U
  1 recall4 reports
• UroPass 61254BX

  ACCESSORIES, CATHETER, G-U
  1 recall4 reports
• UroPass 61324BX

  ACCESSORIES, CATHETER, G-U
  1 recall3 reports
• UroPass 61338BX

  ACCESSORIES, CATHETER, G-U
  1 recall2 reports
• UroPass 61154BX

  ACCESSORIES, CATHETER, G-U
  1 recall1 report
• UroPass 61246BX

  ACCESSORIES, CATHETER, G-U
  1 recall1 report
• UroPass 61346BX

  ACCESSORIES, CATHETER, G-U
  1 recall1 report
• UroPass 61124BX

  ACCESSORIES, CATHETER, G-U
  1 recall0 reports
• UroPass 61354BX

  ACCESSORIES, CATHETER, G-U
  1 recall0 reports

Recent UroPass adverse event reports

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

• MalfunctionNov 11, 2024Break; Break

  IT WAS REPORTED, THE URETERAL CATHETER TIP WAS FOUND TO BE BROKEN WHEN INSPECTED. THE ISSUE OCCURRED DURING RECEIPT INSPECTION. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20657432 ↗
• MalfunctionOct 15, 2024Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE TIP OF THE UROPASS ACCESS SHEATH WAS DAMAGED WHEN IT WAS TAKEN OUT OF THE BOX. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20457753 ↗
• MalfunctionMar 7, 2024Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT DURING A PROCEDURE TO ACCESS THE URETER, THE SURGEON HAD DIFFICULTY INSERTING THE SHEATH. WHEN THE SHEATH WAS TAKEN OUT OF THE PATIENT, THERE WAS A CRACK NOTED NEAR THE TIP AND THE TIP SUBSEQUENTLY BROKE WHEN PLACED ON THE OPERATING TABLE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS AN UNSPECIFIED DELAY; HOWEVER, THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861983 ↗
• 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 ↗
• InjuryJul 18, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  THE OLYMPUS SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DURING THERAPEUTIC URETHERSCOPY, THE TIP OF UROPASS AS 13/15FR X 24 CM 5/BX BROKE AND PART FELL INSIDE THE PATIENT AND PER PHYSICIAN THE TIP IS BELIEVED TO BE INSIDE THE PATIENT. NO TESTS HAVE BEEN PERFORMED TO VERIFY THE STATUS OF THE TIP OF DEVICE. IT WAS STATED THAT THE PROCEDURE WAS COMPLETED AND NO PATIENT HARM OCCURRED. DETAILS OF THE PATIENT'S CURRENT CONDITION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THE REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17342158 ↗
• InjuryJun 9, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC URETEROSCOPY, THIS URETERAL CATHETER TIP BROKE OFF IN PATIENT. THE SURGEON WAS ABLE TO RETRIEVE ALL PARTS FROM THE PATIENT. THE PROCEDURE WAS PROLONGED WITH AN UNKNOWN AMOUNT OF TIME. THE INTENDED PROCEDURE WAS COMPLETED WITH INTERVENTION PROCEDURE. THE DEVICE WAS INSPECTED PRIOR TO USE. THE CUSTOMER CONFIRMED THEY KNEW THE STOCK WAS EXPIRED BUT DECIDED TO USE IT ANYWAY. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100946 ↗
• MalfunctionMay 8, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TIP OF THE OUTER SHEATH OF THE DEVICE WAS TORN AT THE START OF THE PROCEDURE (AN UNSPECIFIED PROCEDURE). THE DEVICE WAS NOT USED ON PATIENT. 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 16892249 ↗
• InjuryApr 27, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING THERAPEUTIC CYSTOSCOPY, URETEROSCOPY AND LASER STONE, THE TIP OF THE UROPASS SHEATH BROKE INSIDE THE PATIENT. THE BITS WERE FISHED OUT OF THE BLADDER. THE PROCEDURE WAS DELAYED FOR FIVE MINUTES AND COMPLETED WITH A DIFFERENT SIZE ACCESS SHEATH. THE DEVICE WAS AN EXPIRED ITEM. THE DEVICE WAS INSPECTED BEFORE USE BUT DID NOT NOTICE IT WAS EXPIRED UNTIL THEY HAD TO "RISKMAN" THE INCIDENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16828705 ↗
• 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 ↗
• InjuryApr 11, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER. THE DEVICE BROKE OFF IN THE PATIENT'S BLADDER. THERE WERE NO ANATOMICAL CHALLENGES OR PROCEDURAL DIFFICULTIES OBSERVED. THERE WAS NO ALLEGATION AGAINST THE OLYMPUS URETEROSCOPE THAT WAS USED CONCOMITANTLY. THE PATIENT HAD BEEN DISCHARGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16718798 ↗
• InjuryMar 14, 2023Break; Break

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT DURING BILATERAL ENDOSCOPIC COMBINED INTRA-RENAL SURGERY (ECIRS) USING THIS URETERAL ACCESS SHEATH, THE TIP OF THE ACCESS SHEATH BROKE WHILE INSIDE THE PATIENT. THE BROKEN TIP HAS BEEN RETRIEVED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542516 ↗
• InjuryMar 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A RETROGRADE INTRARENAL SURGERY, THREE UROPASS URETERAL ACCESS SHEATH BROKE AT THE DISTAL END OF THE DILATOR INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER SHEATH HOWEVER IT WAS SHORTER. THE FRAGMENTS THAT FELL INTO THE PATIENT HAVE BEEN REMOVED BUT CAUSED EXTENSION OF THE PROCEDURE FOR ONE AND A HALF HOURS. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ANESTHETIST REPORTED TO THE PHYSICIAN THAT THE PATIENT HAD AN EARLY PULMONARY EDEMA AND WAS GIVEN A DIURETIC WHICH SEEMED TO HAVE NOT MADE THE PROBLEM MORE SERIOUS. IT WAS THOUGHT TO BE A CONSEQUENCE OF PATIENT BEING UNDER GENERAL ANESTHESIA FOR A TIME LONGER THAN EXPECTED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. (B)(6) 1 OF 3 UROPASS URETERAL ACCESS SHEATH. (B)(6) 2 OF 3 UROPASS URETERAL ACCESS SHEATH. (B)(6) 3 OF 3 UROPASS URETERAL ACCESS SHEATH.

  Patient problems: Pulmonary Edema

  MAUDE report 16492576 ↗
• InjuryMar 6, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A RETROGRADE INTRARENAL SURGERY, THREE UROPASS URETERAL ACCESS SHEATH BROKE AT THE DISTAL END OF THE DILATOR INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER SHEATH HOWEVER IT WAS SHORTER. THE FRAGMENTS THAT FELL INTO THE PATIENT HAVE BEEN REMOVED BUT CAUSED EXTENSION OF THE PROCEDURE FOR ONE AND A HALF HOURS. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE ANESTHETIST REPORTED TO THE PHYSICIAN THAT THE PATIENT HAD AN EARLY PULMONARY EDEMA AND WAS GIVEN A DIURETIC WHICH SEEMED TO HAVE NOT MADE THE PROBLEM MORE SERIOUS. IT WAS THOUGHT TO BE A CONSEQUENCE OF PATIENT BEING UNDER GENERAL ANESTHESIA FOR A TIME LONGER THAN EXPECTED. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. (B)(6) 1 OF 3 UROPASS URETERAL ACCESS SHEATH. (B)(6) 2 OF 3 UROPASS URETERAL ACCESS SHEATH. (B)(6) 3 OF 3 UROPASS URETERAL ACCESS SHEATH.

  Patient problems: Pulmonary Edema

  MAUDE report 16492538 ↗

Other Gyrus ACMI, LLC products

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