UroPass 61224BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00821925035393), received between Jun 22, 2021 and Dec 28, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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.

• InjuryDec 28, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061655 ↗
• InjuryAug 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿THE LUMBOSACRAL ANGLE IS A SIGNIFICANT PREDICTOR FOR USING A SEMI-RIGID URETEROSCOPIC APPROACH IN MIDDLE URETERAL STONES,¿ PATIENTS EXPERIENCED ADVERSE EFFECTS DURING AND OTHER SEMI-RIGID URETEROSCOPIC PROCEDURES. BACKGROUND: URETEROSCOPY FOR MIDDLE URETERAL STONES IS OFTEN DIFFICULT FROM AN ANATOMICAL VIEW. THIS STUDY AIMED TO EVALUATE THE PELVIC ANATOMY IN THREE DIMENSIONS AND INVESTIGATE THE RELATIONSHIP BETWEEN THE PELVIC ANATOMY AND POTENTIAL SEMI-RIGID URETEROSCOPIC APPROACH FOR TREATING MIDDLE URETERAL STONES. METHODS: FROM A TOTAL OF 967 PATIENTS WHO UNDERWENT URETEROSCOPY FROM DECEMBER 2017 TO JANUARY 2021, 124 PATIENTS WHO HAD MIDDLE URETERAL STONES WERE INCLUDED IN THIS RETROSPECTIVE COHORT STUDY. THE PELVIC TRANSVERSE DIAMETER, PELVIC VERTICAL DIAMETER, PELVIC DEPTH, AND LUMBOSACRAL ANGLE WERE MEASURED THROUGH PREOPERATIVE NON-CONTRAST COMPUTED TOMOGRAPHY TO DEFINE THE SHAPE OF THE PELVIC CAVITY. THE RELATIONSHIP BETWEEN THE REACHABILITY OF THE MIDDLE URETERAL STONE USING A SEMI-RIGID URETEROSCOPE AND THE AFOREMENTIONED ANATOMICAL FACTORS, AS WELL AS TREATMENT OUTCOMES, WAS EXAMINED RETROSPECTIVELY. RESULTS: THE LUMBOSACRAL ANGLE

  Patient problems: Fever; Pain; Unspecified Kidney or Urinary Problem

  MAUDE report 15311951 ↗
• MalfunctionDec 8, 2021Break; Break

  AS REPORTED, DURING A URETEROSCOPY PROCEDURE, THE DEVICE BROKE INSIDE OF PATIENT. THE DEVICE FRACTURED IN THE MIDDLE AND IN ANOTHER AREA. THE DEVICE WAS ABLE TO BE RETRIEVED AND THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12965245 ↗
• MalfunctionJun 22, 2021Break; Break

  AN OLYMPUS SALES REPRESENTATIVE REPORTED THAT THE UROPASS ACCESS SHEATH BROKE OFF DURING URETEROSCOPY. THE INSIDE OF THE SHEATH WAS VERY BRITTLE AND ALMOST DRIED OUT. A SCAN WAS PERFORMED AND NO FRAGMENTS COULD BE SEEN IN THE PATIENT. THEREFORE, THE DOCTOR CONCLUDED THAT THE BROKEN PIECE DID NOT REMAIN IN THE BODY. THERE WAS NO PATIENT INJURY OR ADVERSE OUTCOME TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12045296 ↗

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