Medline Industries, Inc. URO175814Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10193489987454), received between May 22, 2023 and Dec 10, 2024 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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.

• InjuryDec 10, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE FACILITY, THE BALLOON WOULD NOT INFLATE AND A NEW CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20893330 ↗
• InjuryDec 10, 2024Inflation Problem; Inflation Problem

  ACCORDING TO THE FACILITY, THE BALLOON WOULD NOT INFLATE. A NEW CATHETER WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892307 ↗
• MalfunctionDec 9, 2024Inflation Problem; Inflation Problem

  BALLOONS WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879878 ↗
• MalfunctionDec 9, 2024Inflation Problem; Inflation Problem

  BALLOONS WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879245 ↗
• InjuryMay 22, 2023Break; Break

  SAMPLE PORT DISLODGED REQUIRING FOLEY CATHETER REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16979900 ↗