Bardex® Lubricath® Hematuria Foley Catheter 2551H24Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741025167), received between Oct 23, 2019 and May 15, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2025Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (HAEMATURIA, BLOCKAGE) ASSOCIATED WITH THE DEVICE 2551H24 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY STRAIGHT TIP, 30/50ML, 24 FR. THE RESPONDENT INDICATED THE PATIENT HAD HAEMATURIA AS WELL PRIOR TO DEVICE PLACEMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS INDICATED FOR THE HAEMATURIA, HOWEVER THE RESPONDENT STATED WHEN THEY HAD BLOCK NON-FOLEY CATHETER, THEY IRRIGATE WITH NORMAL SALINE, AND THEY CHECK FOR KINK AND TWISTING. IF DID NOT AFFECT, THEY HAVE TO REPLACE CATHETER WITH NEW ONE WHEN ASKED ABOUT MEDICAL OR SURGICAL INTERVENTION WHEN RELATED TO THE BLOCKAGE. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT HAD SEPTICAEMIA/UROSEPSIS/WOUND INFECTION PRIOR TO DEVICE PLACEMENT AND AFTER DEVICE PLACEMENT. WHEN RESPONDENT WAS ASKED IF THEY BELIEVED THIS COMPLICATION TO BE DEVICE RELATED AFTER PLACEMENT, THEY STATED THEY THOUGHT DID NOT USE STERILE TECHNIQUE COMPLETELY. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED FALSE PASSAGE CREATION AS A RESULT OF THE DEVICE. WHEN ASKED IF THIS REQUIRED MEDICAL OR SURGICAL INTERVENTION THE RESPONDENT STA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22027325 ↗
• InjuryMay 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT THE PATIENT EXPERIENCED ADVERSE EVENTS (HAEMATURIA, BLOCKAGE) ASSOCIATED WITH THE DEVICE 2551H24 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY STRAIGHT TIP, 30/50ML, 24 FR. THE RESPONDENT INDICATED THE PATIENT HAD HAEMATURIA AS WELL PRIOR TO DEVICE PLACEMENT. NO MEDICAL OR SURGICAL INTERVENTION WAS INDICATED FOR THE HAEMATURIA, HOWEVER THE RESPONDENT STATED WHEN THEY HAD BLOCK NON-FOLEY CATHETER, THEY IRRIGATE WITH NORMAL SALINE, AND THEY CHECK FOR KINK AND TWISTING. IF DID NOT AFFECT, THEY HAVE TO REPLACE CATHETER WITH NEW ONE WHEN ASKED ABOUT MEDICAL OR SURGICAL INTERVENTION WHEN RELATED TO THE BLOCKAGE. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT HAD SEPTICAEMIA/UROSEPSIS/WOUND INFECTION PRIOR TO DEVICE PLACEMENT AND AFTER DEVICE PLACEMENT. WHEN RESPONDENT WAS ASKED IF THEY BELIEVED THIS COMPLICATION TO BE DEVICE RELATED AFTER PLACEMENT, THEY STATED THEY THOUGHT DID NOT USE STERILE TECHNIQUE COMPLETELY. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED FALSE PASSAGE CREATION AS A RESULT OF THE DEVICE. WHEN ASKED IF THIS REQUIRED MEDICAL OR SURGICAL INTERVENTION THE RESPONDENT STA

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

  MAUDE report 22027324 ↗
• MalfunctionApr 7, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT FIXED WATER IN THE FOLEY CATHETER WAS LEAKED. WHEN THE PATIENT COMPLAINED OF DISCOMFORT AND HAD THE DEVICE REMOVED, THERE WAS LESS FIXED WATER.

  Patient problems: Discomfort

  MAUDE report 21784773 ↗
• MalfunctionApr 4, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DIFFICULTY IN INJECTION AND FOLEY CATHETER SHAFT LEAKAGE OF FIXED WATER WERE FOUND DURING PATIENT EXCHANGE. FIXED WATER LEAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773244 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FIXATION WATER LEAKED FROM THE FOLEY CATHETER AND INFUSION DIFFICULTIES FOUND DURING EXCHANGE OF PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21773102 ↗
• MalfunctionJan 2, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PROBE OF FOLEY CATHETER WAS MUCH TOO RIGID, IT WAS REINFORCED INSIDE AND THE HOLES AT THE END WERE TOO SMALL. SURGEONS DID NOT LIKE THEM. THERE WAS RISK OF BIB CAGE AND PATIENT INJURY. THEY NEEDED PROBE FROM THE RIGHT COMPANY IN A SMALLER SIZE OR LARGER SIZE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21057099 ↗
• MalfunctionSep 18, 2020Difficult to Remove; Therapeutic or Diagnostic Output Failure

  IT WAS REPORTED THAT WHEN THE PHYSICIAN WANT TO REMOVE THE CATHETER FROM THE PATIENT, THE CATHETER DID NOT WORK PROPERLY AND COULD NOT BE REMOVED. IT WAS ALSO STATED THE PHYSICIAN HAD TO DO A SPECIAL TREATMENT TO REMOVE THE CATHETER THAT MADE THE PHYSICIAN UNCOMFORTABLE. AS PER THE ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 07SEP2020 FROM THE IBC REPRESENTATIVE, IT WAS FOUND DURING THE PROCESS THAT THE CATHETER WOULD NOT PERFORM PROPERLY AND IT WAS FOUND THE URINE DRAIN PORT WAS CLOGGED, SO THE CATHETER WAS CHANGED TO A NEW ONE.

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

  MAUDE report 10556960 ↗
• MalfunctionOct 23, 2019Misassembled; Material Twisted/Bent; Misassembled

  IT WAS REPORTED THAT THE BLUE CAP WAS FOUND SLANTED UPON USE. THERE WAS NO LEAKAGE OBSERVED.

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

  MAUDE report 9226843 ↗