Medline Industries, Inc. URO175714Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10193489987416), received between Mar 4, 2026 and Sep 11, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deflation 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.

• MalfunctionSep 11, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50734219 ↗
• MalfunctionSep 9, 2026Deflation Problem; Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50698111 ↗
• MalfunctionMar 4, 2026Obstruction of Flow

  ACCORDING TO THE FACILITY, ON (B)(6) 2026, RN INSERTED A FOLEY CATHETER FOLLOWING AN EPIDURAL PLACEMENT FOR A LABORING PATIENT. AFTER PLACEMENT, IT WAS IDENTIFIED THAT URINE WAS NOT ADVANCING FORWARD INTO THE CATHETER EXTENSION TUBING/URINE DRAINAGE BAG. RN ATTEMPTED TO FLUSH CATHETER AND THEN ASSESSED THE CONNECTION LINE, AND ULTIMATELY URINE REMAINED IN STASIS ONCE IT REACHED THE END OF THE INDWELLING DRAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512498 ↗