Medline URO170816TSQRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10193489723427), received between Jul 5, 2022 and Sep 22, 2026 — classified as 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859646 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Connection Problem

  It was reported that temperature probe disengaged from catheter inner lumen and was leaking.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820010 ↗
• MalfunctionSep 15, 2026Material Split, Cut or Torn

  It was reported that Foley balloon burst while patient was sitting in chair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50772749 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  It was reported that "Temperature probe disengaged from catheter inner lumen and was leaking."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691947 ↗
• InjuryJan 8, 2024Material Integrity Problem; Material Integrity Problem

  SYRINGE BROKE WHILE INFLATING FOLEY CATHETER BALLOON.

  Patient problems: Exposure to Body Fluids

  MAUDE report 18466941 ↗
• InjuryApr 25, 2023Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023, THE FOLEY BEGAN TO LEAK AROUND THE BALLOON AND WHEN THE BALLOON WAS CHECKED, URINE CAME OUT OF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16808559 ↗
• InjuryFeb 13, 2023Burst Container or Vessel; Burst Container or Vessel

  ACCORDING TO THE CUSTOMER, ON (B)(6) 2023 A FOLEY WAS INSERTED WITH A GUIDEWIRE FOR A "CYSTO" AND AFTER A "FEW MINUTES" IT WAS NOTED THAT THE FOLEY WAS COMING OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16368433 ↗
• InjuryJul 5, 2022Activation, Positioning or Separation Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2022, THE FOLEY CATHETER BALLOON SPLIT AND THE CATHETER FELL OUT OF THE PATIENT DURING A PROCEDURE.

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

  MAUDE report 14917041 ↗