UroPass 61054BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925035348), received between Nov 17, 2022 and Mar 6, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 16492483 ↗
• InjuryNov 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTS DURING A PERCUTANEOUS NEPHROLITHOTOMY (PCNL) PROCEDURE USING A UROPASS SHEATH, THE DEVICE BROKE OFF AND FELL INTO THE PATIENT. ADDITIONAL DETAILS REGARDING THE PATIENT AND EVENT HAVE BEEN REQUESTED. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15818790 ↗

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