Medline Industries, Inc. URO175816CRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10193489988727), received between Dec 13, 2024 and Sep 16, 2026 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Connection Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Disconnection

  Patient problems: Chemical Exposure; Exposure to Body Fluids

  MAUDE report 50787933 ↗
• MalfunctionSep 14, 2026Connection Problem

  It was reported that "FOLEY CATHETER DID NOT SEAL AT HOSE/BAG AND THE SECURMENT DEVICE DID NOT ADHERE CORRECTLY".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50759114 ↗
• MalfunctionSep 8, 2026Connection Problem

  It was reported that "Catheter disconnected from urine meter during chemotherapy procedure, leading to leakage of urine + chemotherapy drug."

  Patient problems: Chemical Exposure; Exposure to Body Fluids

  MAUDE report 50674490 ↗
• MalfunctionJan 6, 2026Device Dislodged or Dislocated; Unintended Deflation

  IT WAS REPORTED THAT THE PATIENT'S INDWELLING URINARY CATHETER DISLODGED WITH THE BALLOON DEFLATED. RE-CATHETERIZATION WAS REQUIRED. ACCORDING TO THE FACILITY, THE PATIENT STATED THAT THE MEDLINE CATHETER WAS UNCOMFORTABLE AND "CONTINUED TO FALL OUT". THE FACILITY INDICATED THAT A CATHETER FROM A DIFFERENT VENDOR WAS PLACED AFTERWARD.

  Patient problems: Discomfort

  MAUDE report 23984623 ↗
• InjuryMar 3, 2025Material Separation; Material Separation

  ACCORDING TO THE CUSTOMER, THE "BCG MEDICATION" WAS INSERTED INTO THE BLADDER THROUGH THE FOLEY "SIDE PORT" AND AFTER "35 MINUTES" THE FOLEY "CAME APART WHERE THE SILICONE MEETS THE PLASTIC TUBING".

  Patient problems: Chemical Exposure

  MAUDE report 21509737 ↗
• MalfunctionFeb 19, 2025Leak/Splash; Leak/Splash

  ACCORDING TO THE CUSTOMER, THE "BCG MEDICATION" WAS INSERTED INTO THE BLADDER THROUGH THE FOLEY "SIDE PORT" AND AFTER "35 MINUTES" THE FOLEY "CAME APART WHERE THE SILICONE MEETS THE PLASTIC TUBING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21415198 ↗
• MalfunctionDec 13, 2024Deflation Problem; Deflation Problem

  ACCORDING TO THE FACILITY ON (B)(6) 2024 THE BALLOON FOR A FOLEY CATHETER DEFLATED REQUIRING A NEW CATHETER TO BE INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20924225 ↗