Uretero1 UROSD101Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00724995209162), received between Jan 6, 2026 and Apr 23, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 reports).

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.

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.

• MalfunctionApr 23, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE SCREEN TO THEIR URETERO1 STANDARD DEFLECTION DISPOSABLE URETEROSCOPE WAS SHOWING LINES AND FLICKERING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT URETEROSCOPE. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24964568 ↗
• MalfunctionJan 6, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE NO IMAGE APPEARED ONCE THEIR URETERO1 SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE WAS CONNECTED TO THE MONITOR. ANOTHER DEVICE WAS UTILIZED FOR THE PATIENT PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974204 ↗
• MalfunctionJan 6, 2026Display or Visual Feedback Problem

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A DISTORTED IMAGE APPEARED ONCE THEIR URETERO1 SINGLE-USE DIGITAL FLEXIBLE URETEROSCOPE CONNECTED TO THE MONITOR. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23973424 ↗