Medline URO170818SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889942126910), received between Sep 17, 2025 and Sep 14, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Unintended Deflation

  It was reported that RN reported foley to be inserted, but deflated on 4 separate kits.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50756382 ↗
• InjurySep 17, 2025Obstruction of Flow; Obstruction of Flow

  ACCORDING TO THE FACILITY, ON (B)(6) 2025, IT WAS NOTICED THAT THE FOLEY CATHETER WAS NOT DRAINING PROPERLY. CATHETER WAS REMOVED AND THEN PATIENT WAS STRAIGHT CATHED WITH LARGE AMOUNT OF URINE COLLECTED. FACILITY REPORTS NO SERIOUS INJURY. INDIVIDUAL IS DOING "FINE."

  Patient problems: Urinary Retention

  MAUDE report 23077466 ↗