Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741025174), received between Mar 31, 2022 and Mar 13, 2026 — classified as 3 injuries, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Material Rupture

  IT WAS REPORTED THAT THERE WERE PATIENT HARM AND DEVICE BURST DURING SURGERY.

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

  MAUDE report 24595649 ↗
• MalfunctionMay 30, 2025Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT IN THE ONLINE SURVEY A NURSE STATED THAT THEY WERE NOT ABLE TO SUCCESSFULLY IRRIGATE THE PATIENT WHILE Y USING 2557H20 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 20 FR. BECAUSE OF "PASSAGE RELATED".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22114084 ↗
• InjuryOct 10, 2023Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSTALLED ON (B)(6) 2023. ON (B)(6), IT WAS IMPOSSIBLE TO DEFLATE THE BALLOON. SEEN WITH THE DOCTOR WHO PUNCTURED THE BALLOON.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17906635 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED HEMATURIA AND LEAKAGE WHEN ASKED IF THEY EXPERIENCED COMPLICATIONS USING THE HYDROGEL COATED PROSTATIC CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135357 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, HEMATURIA, BLADDER FISTULA, URETHRAL OR BLADDER TRAUMA, URETHRAL SPHINCTER DYSFUNCTION AND LEAKAGE WHILE USING THE BARD 3-WAY 30CC HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134911 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT PAIN, HEMATURIA, BLADDER FISTULA, URETHRAL OR BLADDER TRAUMA, URETHRAL SPHINCTER DYSFUNCTION AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE BARD 3-WAY 30CC DELINOTTE HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14134835 ↗
• InjuryApr 12, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT WHEN USER WAS ASKED IF THEY EXPERIENCED COMPLICATIONS USING THE FOLEY CATHETER, USER STATED THEY EXPERIENCED PAIN AND BACTERIURIA. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 14083648 ↗
• MalfunctionApr 1, 2022Partial Blockage; Partial Blockage

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13973330 ↗
• InjuryMar 31, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT HEMATURIA, EPIDIDYMITIS, URETHRAL OR BLADDER TRAUMA, BLADDER CANCER, BLADDER PERFORATION, URETHRAL SPHINCTER DYSFUNCTION AND INCONTINENCE WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. ALSO THE CATHETER WAS REMOVED ACCIDENTALLY AND THERE WERE FEW RETAINED FRAGMENTS FROM THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria; Perforation; Urinary Incontinence

  MAUDE report 13959676 ↗