MEDLINE URO175814TRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489987522), received between May 18, 2023 and Sep 7, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Integrity Problem” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY ON (B)(6) 2023 THE "FOLEY CATHETER WOULD NOT DRAIN URINE, ATTEMPTS TO FLUSH CATHETER WERE UNSUCCESSFUL AND THE CATHETER WAS EXCHANGED FOR PATIENT SAFETY".

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

  MAUDE report 17703976 ↗
• InjuryMay 19, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY THE SAMPLE PORT DETACHED REQUIRING THE CATHETER TO BE REPLACED.

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

  MAUDE report 16961433 ↗
• InjuryMay 18, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE FACILITY THE SAMPLE PORT OCCLUDED REQUIRING THE CATHETER TO BE REPLACED.

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

  MAUDE report 16952892 ↗