UroPass 61324BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00821925035430), received between Jan 11, 2021 and Jul 18, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjuryDec 28, 2022Material Separation; Material Separation

  C22475559 MODEL# 61154BX / LOT # 09J1800111

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062156 ↗
• MalfunctionJan 11, 2021Device Fell; Device Fell

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DEVICE TIP FELL OFF INTO THE PATIENT. THE BROKEN TIP WAS RETRIEVED USING A BASKET. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE WITH THE SAME DEVICE MODEL NUMBER (61324BX). THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11149818 ↗

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