Bardex® Lubricath® Hematuria Coude Foley Catheter 2556H22Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741025129), received between Mar 13, 2019 and May 2, 2025 — classified as 1 injury, 9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CRITICAL CARE NURSE IN THE ONLINE SURVEY STATED THAT SUCCESSFUL DRAINAGE OF URINE WAS NOT ACHIEVED FROM USE OF THIS PRODUCT (1856H22 BARD 2-WAY DUFOUR HYDROGEL COATED PROSTATIC CATHETER, 30/50 ML, 22 FR.) FOR THE SPECIFIED DURATION OF USE BECAUSE OF "IT WAS LEAKING." PER FOLLOW UP INFORMATION RECEIVED VIA IBC ON 23APR2025, STATED THAT THE ISSUE WAS WITH THE PATIENT BECAUSE NO MATTER THE SIZE OF THE CATHETER, THERE WILL STILL BE A BYPASS AND THE INTENDED REASON FOR USE WAS NOT ACHIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950211 ↗
• MalfunctionApr 1, 2022Calcified; Calcified

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE, BLADDER STONES, BLADDER CANCER, BLADDER PERFORATION AND URETHRAL SPHINCTER DYSFUNCTION WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE HEMATURIA 2WAY 30CC COUDE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981374 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE, BLADDER STONE(S), BLADDER CANCER, BLADDER PERFORATION AND URETHRAL SPHINCTER DYSFUNCTION WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE HEMATURIA 2WAY 30CC COUDE CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13981322 ↗
• MalfunctionApr 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT LEAKAGE, BLADDER STONE(S), BLADDER CANCER, BLADDER PERFORATION AND URETHRAL SPHINCTER DYSFUNCTION WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. NO MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13979922 ↗
• MalfunctionJul 26, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT HAD ISSUES WITH A CLOGGED FOLEY CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12224315 ↗
• MalfunctionJun 23, 2021Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY CATHETERS WERE CLOGGING. ALSO STATED THAT THE MOST RECENT ONE THAT THE PATIENT HAD IN MIGHT BE A WEEK WAS ALREADY TOO CLOGGED TO DRAIN OR IRRIGATE AND THE PATIENT HAD REPLACED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054778 ↗
• MalfunctionNov 12, 2020Inaccurate Flow Rate; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH CATHETERS. PATIENT STATED THEY JUST HAD NURSE PUT THE LAST ONE IN. PATIENT'S NURSE WAS NOT ABLE TO GET ANY FLUID TO FLUSH THROUGH THE FOLEY EVEN AFTER TOOK IT OUT. AS A RESULT SOMETIMES THE URINE BACKS UP AND LEAKS OUT BY WHERE PATIENT INSERTS IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10828924 ↗
• MalfunctionAug 13, 2020Filling Problem; Failure to Infuse; Failure to Infuse

  IT WAS REPORTED THAT THE BALLOON STOPPED FILLING AFTER TWO WEEKS. ALSO STATED THAT THE PATIENT ONLY PUTS 10CC.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404706 ↗
• MalfunctionSep 3, 2019Deflation Problem; Fluid/Blood Leak; Deflation Problem

  IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON LEAKED WATER AND AS A RESULT CAUSED PREMATURE DEFLATION OF THE BALLOON. THEREFORE, THE FOLEY WAS REMOVED AND REPLACED.

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

  MAUDE report 8956383 ↗
• MalfunctionMar 13, 2019Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE CATHETER WAS CLOGGED AND DID NOT ALLOW ALL OF THE URINE TO FLOW OUT TO THE BAG. THE PATIENT STATED THAT THE DRAIN BAG WAS CHANGED EVERY FOUR WEEKS. NO MEDICAL INTERVENTION REPORTED.

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

  MAUDE report 8418585 ↗