Medline Industries, Inc. URO175116Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10193489987294), received between Sep 7, 2023 and Sep 17, 2026 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Fluid/Blood Leak

  It was reported that "Drain bag leaking at seams."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50806190 ↗
• MalfunctionMar 2, 2026Material Puncture/Hole

  CATHETER HAD A HOLE.

  Patient problems: Insufficient Information

  MAUDE report 24482200 ↗
• MalfunctionJan 29, 2026Complete Blockage

  ACCORDING TO THE FACILITY, THE PATIENT WAS TRANSFERRED TO THE TRANSPLANT UNIT ON (B)(6) 2026 WITH A MEDLINE FOLEY CATHETER IN PLACE, WHICH WAS NOTED TO BE DRAINING APPROPRIATELY. THE REPORTER OBSERVED THE PATIENT ON (B)(6) 2026 WITH THE MEDLINE FOLEY CONTINUING TO DRAIN WITHOUT DIFFICULTY. ON (B)(6), THE FOLEY COLLECTION BAG WAS NOTED TO HAVE NO URINE OUTPUT. A BLADDER SCAN PERFORMED BY NURSING STAFF SHOWED APPROXIMATELY 400 ML IN THE BLADDER. THE NURSE REMOVED THE MEDLINE FOLEY CATHETER USING A SLOW, ROTATING MOTION, AND NO URINE DRAINED DURING REMOVAL. UPON INSPECTION OF THE REMOVED CATHETER, THE REPORTER DOCUMENTED THAT THERE WERE NO KINKS, NO SEDIMENT, AND THE EYELETS WERE OPEN. A BARD COUDE FOLEY CATHETER WAS THEN INSERTED BY NURSING STAFF, AND APPROXIMATELY 400 ML DRAINED IMMEDIATELY. THE BARD FOLEY CONTINUED TO DRAIN APPROPRIATELY THEREAFTER. THE PATIENT HAD PREEXISTING CONDITIONS AND HAD BEEN USING FOLEY CATHETERS INTERMITTENTLY POST SURGERY DUE TO THESE ISSUES. INCREASED ABDOMINAL PRESSURE WAS PRESENT PRIOR TO FOLEY USE AND WAS ATTRIBUTED TO OTHER CONDITIONS.

  Patient problems: Urinary Retention

  MAUDE report 24214717 ↗
• MalfunctionOct 15, 2025Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  IT WAS REPORTED THAT THE CLINICIAN HAD "DIFFICULTY SECURING THE SYRINGE TO THE CATHETER FOR BALLOON INFLATION" AND "MORE FORCE WAS NEEDED TO INSERT THE SYRINGE".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23291212 ↗
• InjuryJun 24, 2025Material Integrity Problem; Material Integrity Problem

  ACCORDING TO THE FACILITY, THE "CATHETER BALLOONS KEEP BREAKING" CAUSING A NEW CATHETER TO BE PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22319630 ↗
• MalfunctionJun 24, 2025Material Integrity Problem; Material Integrity Problem

  FAILURE OF FOLEY CATHETER BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 22319282 ↗
• MalfunctionJun 24, 2025Material Integrity Problem; Material Integrity Problem

  FAILURE OF FOLEY CATHETER BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 22318658 ↗
• InjuryJun 20, 2025Material Integrity Problem; Material Integrity Problem

  FAILURE OF FOLEY CATHETER BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 22300625 ↗
• MalfunctionNov 1, 2024Inflation Problem; Inflation Problem

  FOLEY BALLOON NOT INFLATING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588393 ↗
• InjurySep 7, 2023Leak/Splash; Leak/Splash

  ACCORDING TO THE FACILITY ON (B)(6) 2023 "THE PATIENT'S FOLEY CATHETER WOULD NOT DRAIN URINE CAUSING THE FOLEY CATHETER TO BE EXCHANGED DUE TO ISSUES".

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

  MAUDE report 17703699 ↗