Medline URO170114QRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489442120), received between Mar 30, 2023 and Sep 15, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

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.

• MalfunctionSep 15, 2026Loss of or Failure to Bond; Detachment of Device or Device Component

  It was reported that "Detached Sample Port" and "Pt ripped off sample port."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778004 ↗
• MalfunctionSep 9, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50696983 ↗
• InjuryJul 6, 2023Infusion or Flow Problem; Infusion or Flow Problem

  FOLEY CATHETER NOT DRAINING AND CATHETER WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266287 ↗
• InjuryMay 4, 2023Break; Break

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023, THE END OF THE SYRINGE "BROKE OFF" IN THE FOLEY PORT AND A NEW CATHETER WAS REQUIRED TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869874 ↗
• InjuryMar 30, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE SAMPLE PORT WAS LEAKING AND FELL OFF REQUIRING THE FACILITY TO REPLACE THE FOLEY CATHETER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 16645003 ↗