Medline URO170814Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277866645), received between Mar 23, 2021 and Sep 24, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Complete Blockage; Fluid/Blood Leak

  It was reported that the patient had a 14 French foley catheter placed. Staff attempted to empty the foley bag and noted the green drainage tube would not drain, and the bag itself appeared to be vacuum sealed together.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50888794 ↗
• MalfunctionSep 22, 2026Break

  It was reported that "Med Surg has reported 3 different instances where the 10ml NS syringe slip-tip has broken off into the male adapter of the balloon fill portal. All 3 times the syringe came from a foley catheter tray."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50854043 ↗
• MalfunctionSep 8, 2026Break

  It was reported that "Med Surg has reported 3 different instances where the 10ml NS syringe slip-tip has broken off into the male adapter of the balloon fill portal. All 3 times the syringe came from a foley catheter tray."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50668678 ↗
• MalfunctionJul 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A URINE COLLECTION BAG ON A FOLEY CATHETER WAS LEAKING AND A NEW CATHETER WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579949 ↗
• InjuryAug 12, 2024Crack; Crack

  ACCORDING TO THE FACILITY, "THE BLUE RUBBER DRAINAGE PORT CONNECTED TO THE DRAIN BAG DEVELOPS CRACK/TEAR WHEN THEY CLAMP AND UNCLAMP IT TO DRAIN THE URINE FROM THE BAG. A NEW CATHETER WAS INSERTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19960786 ↗
• MalfunctionMar 23, 2021Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED, A MALE PATIENT HAD THREE FOLEY CATHETER REPLACED DUE TO THE BALLOON DEVELOPING A SLIT AND DEFLATING AFTER INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11556039 ↗