UroPass 61138BXRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00821925035362), received between Apr 14, 2021 and Dec 28, 2022 — classified as 1 injury, 4 malfunctions.

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 5 most recent of 5 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 16062697 ↗
• MalfunctionNov 16, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, AT PREPARATION FOR USE, THE USER TRIED TO USE THE PRODUCT AFTER OPENING , HOWEVER, IT WAS STATED THAT IT WAS DIFFICULT TO USE DUE TO THE PRODUCT WAS BENT SIGNIFICANTLY COMPARED TO THE NORMAL PRODUCT. ACCORDING TO THE REPORT, IT WAS STATED THAT THE PRODUCT ITSELF TOO STIFF AND CURVED, MAKING IT DIFFICULT TO USE FOR PATIENTS. THE DEVICE WAS REPLACED . THE INTENDED THERAPEUTIC RIRS (RETROGRADE INTRARENAL SURGERY) PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. NO PATIENT HARM , NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15807169 ↗
• MalfunctionApr 15, 2021Break; Break

  DURING A THERAPEUTIC URETEROSCOPY PROCEDURE THE USER ATTEMPTED 3 DIFFERENT ACCESS SHEATHS AND EACH TIME, THE END TIP OF THE INNER INTRODUCER CRUMBLED. FOR THE TWO SHEATHS THE ISSUE WAS FOUND BEFORE IT WAS INSERTED/USED ON THE PATIENT. THE PARTS FELL INSIDE THE PATIENTS¿ KIDNEY WHEN THE THIRD SHEATH WAS USED. THE DEVICE WAS VISUALLY INSPECTED PRIOR TO BEING INSERTED AND THE DEVICE APPEARED TO BE INTACT WHEN IT WAS INSERTED. UNDER THE ENDOSCOPIC IMAGE THE PARTS THAT FELL WERE REMOVED USING A COOK BASKET WITH MODEL NUMBER UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SHEATHS WITH MODEL NO.61146BX, LOT NO. 09L1900159. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. THERE WAS NO USER INJURY REPORTED. THIS REPORT IS RELATED TO REPORTS PATIENT IDENTIFIER (B)(6) AND (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670708 ↗
• MalfunctionApr 14, 2021Break; Break

  DURING A THERAPEUTIC URETEROSCOPY PROCEDURE THE USER ATTEMPTED 3 DIFFERENT ACCESS SHEATHS AND EACH TIME, THE END TIP OF THE INNER INTRODUCER CRUMBLED. FOR THE TWO SHEATHS THE ISSUE WAS FOUND BEFORE IT WAS INSERTED/USED ON THE PATIENT. THE PARTS FELL INSIDE THE PATIENTS¿ KIDNEY WHEN THE THIRD SHEATH WAS USED. THE DEVICE WAS VISUALLY INSPECTED PRIOR TO BEING INSERTED AND THE DEVICE APPEARED TO BE INTACT WHEN IT WAS INSERTED. UNDER THE ENDOSCOPIC IMAGE THE PARTS THAT FELL WERE REMOVED USING A COOK BASKET WITH MODEL NUMBER UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SHEATHS WITH MODEL NO.61146BX, LOT NO. 09L1900159. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. THERE WAS NO USER INJURY REPORTED. THIS REPORT IS RELATED TO REPORTS PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667842 ↗
• MalfunctionApr 14, 2021Break; Break

  DURING A THERAPEUTIC URETEROSCOPY PROCEDURE THE USER ATTEMPTED 3 DIFFERENT ACCESS SHEATHS AND EACH TIME, THE END TIP OF THE INNER INTRODUCER CRUMBLED. FOR THE TWO SHEATHS THE ISSUE WAS FOUND BEFORE IT WAS INSERTED/USED ON THE PATIENT. THE PARTS FELL INSIDE THE PATIENTS¿ KIDNEY WHEN THE THIRD SHEATH WAS USED. THE DEVICE WAS VISUALLY INSPECTED PRIOR TO BEING INSERTED AND THE DEVICE APPEARED TO BE INTACT WHEN IT WAS INSERTED. UNDER THE ENDOSCOPIC IMAGE THE PARTS THAT FELL WERE REMOVED USING A COOK BASKET WITH MODEL NUMBER UNKNOWN. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SHEATHS WITH MODEL NO.61146BX, LOT NO. 09L1900159. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. THERE WAS NO USER INJURY REPORTED. THIS REPORT IS RELATED TO REPORTS PATIENT IDENTIFIERS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11667814 ↗

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