Medline URO170808Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889942213467), received between Nov 10, 2025 and Sep 10, 2026 — classified as 1 injury, 2 malfunctions.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2026Detachment of Device or Device Component

  It was reported that In PICU: Foley inserted (b)(6) 2024; Sample port came out during flushing while removing the syringe.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50714427 ↗
• MalfunctionNov 18, 2025Break; Material Integrity Problem; Break; Material Integrity Problem

  ACCORDING TO THE FACILITY, THE SAMPLE PORT DETACHED ON THE CATHETER AND CATHETER WAS REPLACED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582551 ↗
• InjuryNov 10, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT STAFF HAD DIFFICULTY INFLATING AND DEFLATING THE BALLOON DURING USE. MULTIPLE TRAYS WERE ATTEMPTED; TWO FAILED TO INFLATE INSIDE THE PATIENT, AND A THIRD INFLATED OUTSIDE BUT DID NOT FULLY DEFLATE. FOURTH ATTEMPT WAS SUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511250 ↗