Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H24Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741025198), received between May 15, 2018 and Nov 7, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED FROM THE UROLOGY SERVICE COORDINATOR THERE THAT (B)(6). THEY WERE HOPING THEY COULD HELP THEM OUT. THEY WERE HAVING SOME ISSUES WITH THE LUBRICATH HEMATURIA FOLEY CATHETERS. THE 22F AND 24F (REF 2557H22 AND 2557H24) WERE HAVING ISSUES WITH THE INFLOW PORT NOT WORKING PROPERLY AND THE BALLOON HAVING ISSUES WITH DEFLATING. THOSE ISSUES THAT LEAD TO RISKY CATHETER CHANGES AFTER A DELICATE PROCEDURE CAUSING EITHER ADDITIONAL BLEEDING AND/OR ADDITIONAL PROCEDURES.

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

  MAUDE report 23497562 ↗
• InjuryApr 1, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, PAIN AND RETAINED FRAGMENTS FROM CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION IS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13977393 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, PAIN AND RETAINED FRAGMENTS FROM CATHETER WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE FOLEY CATHETER. MEDICAL INTERVENTION WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971478 ↗
• MalfunctionMar 31, 2022Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE CUSTOMER MENTIONED ABOUT CATHETER BLOCKAGE, LEAKAGE, PAIN AND RETAINED FRAGMENTS FROM CATHETER WHEN THEY WERE ASKED ABOUT THE COMPLICATIONS WHILE USING THE FOLEY CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13959924 ↗
• MalfunctionJun 23, 2021Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT A HOLE WAS FOUND IN THE FOLEY CATHETER WHICH LEAKED IRRIGATION AND TWO CATHETERS WERE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12054180 ↗
• MalfunctionJan 3, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A PUNCTURE IN THE BALLOON SURFACE AFTER INSERTING THE HEMATURIA CATHETER AND FILLING THE BALLOON WITH LIQUID. HENCE THE CATHETER COULD NOT REMAIN IN PLACE AND WAS REPLACED BY ANOTHER.

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

  MAUDE report 11105626 ↗
• InjuryFeb 12, 2020Deflation Problem; Entrapment of Device; Deflation Problem

  IT WAS REPORTED THAT THE CATHETER GOT STUCK IN THE PATIENT'S URETHRA. THE CATHETER WAS REMOVED BY SURGERY.

  Patient problems: Foreign Body In Patient; Patient Problem/Medical Problem

  MAUDE report 9701924 ↗
• InjuryFeb 21, 2019Inaccurate Flow Rate; Infusion or Flow Problem; Inaccurate Flow Rate

  IT WAS REPORTED THAT THE CATHETER DID NOT VOID AT ALL. ALLEGEDLY, AS A RESULT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN URINARY TRACT INFECTION. THE INFECTION WAS TREATED WITH ANTIBIOTICS.

  Patient problems: Urinary Tract Infection

  MAUDE report 8359209 ↗
• MalfunctionMay 15, 2018Material Rupture; Hole In Material; Material Rupture

  IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE CATHETER BALLOON WHEN IT WAS REMOVED FROM THE PATIENT. NO PIECES OF THE BALLOON WERE REPORTED MISSING AND NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 7516436 ↗