Bardex® Lubricath® Hematuria Foley Catheter 2550H20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741025082), received between Sep 10, 2020 and Apr 18, 2022 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 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 CATHETER BLOCKAGE, LEAKAGE, RETAINED FRAGMENTS FROM CATHETER, PAIN, HEMATURIA, EPIDIDYMITIS, BOWEL INJURY, URETHRAL SPHINCTER DYSFUNCTION AND INCONTINENCE CAUSED BY FOLEY CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE BARD 2-WAY STRAIGHT TIP HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hematuria; Incontinence; Pain; Unspecified Gastrointestinal Problem

  MAUDE report 14135541 ↗
• InjuryApr 18, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, RETAINED FRAGMENTS FROM CATHETER, PAIN, HEMATURIA, EPIDIDYMITIS, BOWEL INJURY, URETHRAL SPHINCTER DYSFUNCTION AND INCONTINENCE CAUSED BY FOLEY CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE BARD 2-WAY STRAIGHT TIP HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14135536 ↗
• MalfunctionApr 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, RETAINED FRAGMENTS FROM CATHETER, PAIN, HEMATURIA, EPIDIDYMITIS, BOWEL INJURY, URETHRAL SPHINCTER DYSFUNCTION AND INCONTINENCE CAUSED BY FOLEY CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE BARD 2-WAY STRAIGHT TIP HYDROGEL COATED PROSTATIC CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135077 ↗
• MalfunctionApr 15, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, RETAINED FRAGMENTS FROM THE CATHETER, PAIN, HEMATURIA, EPIDIDYMITIS, BOWEL INJURY, URETHRAL SPHINCTER DYSFUNCTION AND INCONTINENCE CAUSED BY FOLEY CATHETER WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS FACED WHILE USING THE BARD 2-WAY STRAIGHT TIP HYDROGEL COATED PROSTATIC CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14120943 ↗
• MalfunctionSep 10, 2020Burst Container or Vessel; Device Slipped; Material Split, Cut or Torn; Burst Container or Vessel

  IT WAS REPORTED THAT THE CATHETER FELL OUT DUE TO THE BALLOON TEAR ON THE 4TH DAY OF ITS USE.

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

  MAUDE report 10519003 ↗