Medline URO170818Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888277862630), received between Mar 5, 2025 and Mar 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE FACILITY, ON (B)(6) 2025 "WHILE DRAWING URINE CULTURE FROM SAMPLE PORT, THE PORT SNAPPED OFF CAUSING LEAKAGE OF URINE, A BREAK IN STERILITY, AND THE FOLEY CATHETER NEEDED TO BE EXCHANGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21536687 ↗
• InjuryMar 5, 2025Break; Leak/Splash; Break; Leak/Splash

  ACCORDING TO THE FACILITY, "WHILE DRAWING URINE CULTURE FROM SAMPLE PORT, THE PORT SNAPPED OFF CAUSING LEAKAGE OF URINE, A BREAK IN STERILITY, AND THE FOLEY CATHETER NEEDED TO BE EXCHANGED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21528780 ↗