Bardex® Lubricath® Temperature-Sensing Foley Catheter 119416Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00801741076947), received between May 30, 2018 and Sep 16, 2022 — classified as 22 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (9 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT SYMPTOMATIC URINARY TRACT INFECTION AND ACCIDENTAL REMOVAL WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 15437556 ↗
• MalfunctionSep 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE , LEAKAGE, HEMATURIA, ACCIDENTAL REMOVAL WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437416 ↗
• MalfunctionSep 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, ACCIDENTAL REMOVAL, BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, URETHRAL OR BLADDER TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437412 ↗
• InjurySep 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE , ACCIDENTAL REMOVAL , BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION, URETHRAL OR BLADDER TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 15437410 ↗
• MalfunctionSep 16, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED CATHETER BLOCKAGE, LEAKAGE, HEMATURIA, ACCIDENTAL REMOVAL WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437284 ↗
• MalfunctionMay 6, 2022Partial Blockage; Partial Blockage

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14310957 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED SYMPTOMATIC URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 14282010 ↗
• MalfunctionMay 4, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272441 ↗
• MalfunctionMay 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14272004 ↗
• MalfunctionApr 29, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION AND CATHETER BLOCKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS FACED WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14255260 ↗
• InjuryApr 29, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT GH PATIENT, SMALL LUMEN RESULTED IN CLOT OCCLUSION, BACTERIURIA, HEMATURIA, CATHETER BLOCKAGE AND LEAKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS FACED WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 14255040 ↗
• MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240747 ↗
• MalfunctionApr 28, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL LUMEN WHICH RESULTED IN CLOT OCCLUSION, BACTERIURIA, HEMATURIA, CATHETER BLOCKAGE AND LEAKAGE AS THE COMPLICATIONS WHILE USING TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240216 ↗
• MalfunctionApr 28, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED SMALL LUMEN WHICH RESULTED IN CLOT OCCLUSION, BACTERIURIA, HEMATURIA, CATHETER BLOCKAGE AND LEAKAGE AS THE COMPLICATIONS WHILE USING TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14240107 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA, SYMPTOMATIC URINARY TRACT INFECTION AND BLOCKAGE 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; Urinary Tract Infection

  MAUDE report 14240056 ↗
• MalfunctionApr 28, 2022Partial Blockage; Partial Blockage

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14239752 ↗
• InjuryApr 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT BACTERIURIA, PAIN AND LEAKAGE 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 14225660 ↗
• MalfunctionApr 27, 2022Partial Blockage; Partial Blockage

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14219478 ↗
• MalfunctionApr 27, 2022Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT GH PATIENT, SMALL LUMEN RESULTED IN CLOT OCCLUSION, BACTERIURIA, HEMATURIA ,CATHETER BLOCKAGE AND LEAKAGE WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218259 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED SYMPTOMATIC URINARY TRACT INFECTION, PAIN, HEMATURIA AND BLADDER FISTULA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fistula; Hematuria; Urinary Tract Infection

  MAUDE report 14218253 ↗
• InjuryApr 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED SYMPTOMATIC URINARY TRACT INFECTION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: Urinary Tract Infection

  MAUDE report 14218176 ↗
• InjuryApr 27, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED URETHRAL OR BLADDER TRAUMA WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

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

  MAUDE report 14218128 ↗
• MalfunctionApr 26, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE , BLADDER PERFORATION WHEN THEY WERE ASKED OF THE COMPLICATIONS WHILE USING THE TEMPERATURE SENSING FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14212949 ↗
• 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 14205604 ↗
• 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 14205591 ↗