Bardex® Lubricath® Foley Catheter Coude Tip 0100L16Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741017872), received between Sep 10, 2018 and Apr 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PT SAID THAT THERE WERE LEAKS WHERE THE TUBING CONNECTED TO CATH. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24958727 ↗
• MalfunctionJul 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER BALLOON DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22412780 ↗
• MalfunctionJun 27, 2023Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS A CONSTANT LEAK, THE TIP OF PRODUCT ONLY HAD ONE HOLE, SUPPOSED TO HAVE 2. THE BATCH OF 6 RECEIVED HAD ALL OF THE SAME ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210383 ↗
• MalfunctionJun 27, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT URINE WAS POURING FROM THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208298 ↗
• MalfunctionNov 5, 2020Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT PATIENT EXPERIENCED BALLOON RUPTURED WHICH RESULTED TO FOLEY CAME OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10792805 ↗
• MalfunctionSep 10, 2018Leak/Splash

  IT WAS REPORTED THAT THE COUDE CATHETER LEAKED AND HAD TO BE REMOVED WEEKLY. NO MEDICAL INTERVENTION REQUIRED. NO PATIENT INJURY REPORTED. HOWEVER, THE PATIENT EXPERIENCED SOME DISCOMFORT.

  Patient problems: Discomfort; No Known Impact Or Consequence To Patient

  MAUDE report 7860654 ↗