Medline URO170814TRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10888277868335), received between Mar 21, 2023 and Sep 14, 2023 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE FOLEY CATHETER NEEDED TO BE REPLACED DUE TO THE SAMPLE PORT DETACHING DURING USE.

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

  MAUDE report 17749540 ↗
• InjuryApr 3, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY (B)(6) 2023 THE SAMPLE PORT DETACHED AND "THE RN REMOVED THE FOLEY WITH THE DETACHED SAMPLE PORT AND INSERTED A NEW FOLEY CATHETER".

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

  MAUDE report 16664876 ↗
• MalfunctionMar 24, 2023Fluid/Blood Leak; Fluid/Blood Leak

  CATHETER LEAKING AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16615971 ↗
• InjuryMar 21, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE SAMPLE PORT DETACHED FROM THE FOLEY CATHETER, REQUIRING THE FACILITY TO REMOVE AND REPLACE THE FOLEY CATHETER.

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

  MAUDE report 16583890 ↗