Bardex® Lubricath® Temperature-Sensing Foley Catheter 119418Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741076954), received between Oct 4, 2021 and May 7, 2022 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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.

• InjuryMay 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA AND PAIN WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 14315810 ↗
• MalfunctionMay 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310969 ↗
• InjuryApr 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BLADDER PERFORATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Perforation

  MAUDE report 14218257 ↗
• InjuryApr 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT SYMPTOMATIC URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR SYMPTOMATIC URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 14213184 ↗
• MalfunctionApr 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT PAIN, HEMATURIA AND LEAKAGE WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14189207 ↗
• MalfunctionOct 4, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS LEAKING ON THE BED IN INTENSIVE CARE UNIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568280 ↗