Bardex® Lubricath® Hematuria Coude Foley Catheter 2557H22Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741025181), received between Mar 19, 2019 and Feb 12, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2026Flaked

  IT WAS REPORTED THAT WHEN THE CUSTOMER WENT TO USE THE FOLEY CATHETER THE INTERNAL LINING WAS SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24327936 ↗
• InjuryNov 7, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED FROM THE UROLOGY SERVICE COORDINATOR THERE THAT (B)(6) MEDICAL CENTER. THEY WERE HOPING THEY COULD HELP THEM OUT. THEY WERE HAVING SOME ISSUES WITH THE LUBRICATH HEMATURIA FOLEY CATHETERS. THE 22F AND 24F (REF (B)(4)) 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 23497563 ↗
• 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, URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 2557H22 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 22 FR. AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED SEPTICAEMIA/UROSEPSIS/WOUND INFECTION, BUT WHEN ASKED TO SPECIFY IF THE COMPLICATION WAS DEVICE RELATED INDICATED URINE RETENTION COULD INCREASE CHANCE TO SPREAD INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22028033 ↗
• 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 (BLOCKAGE, URINARY SYMPTOMS (DYSURIA, INFLAMMATION, ITCHING, BURNING, IRRITATION, FREQUENCY, URGENCY)) ASSOCIATED WITH THE DEVICE 2557H22 BARD HYDROGEL COATED PROSTATIC CATHETER, 3-WAY DUFOUR, 30/50ML, 22 FR. AND IT DID NOT RESULTED IN PATIENT INJURY REQUIRING MEDICAL OR SURGICAL INTERVENTION AND THE COMPLICATION WAS NOT PRESENT PRIOR TO DEVICE PLACEMENT. ADDITIONALLY, THE RESPONDENT INDICATED THE PATIENT EXPERIENCED SEPTICAEMIA/UROSEPSIS/WOUND INFECTION, BUT WHEN ASKED TO SPECIFY IF THE COMPLICATION WAS DEVICE RELATED INDICATED URINE RETENTION COULD INCREASE CHANCE TO SPREAD INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burning Sensation; Dysuria; Inflammation; Itching Sensation; Micturition Urgency; Sepsis; Skin Inflammation/ Irritation; Unspecified Infection; Urinary Frequency / Polyuria; Urinary Retention

  MAUDE report 22028027 ↗
• MalfunctionOct 1, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT 2 OF THE RIBBED BALLOON FOLEY CATHETERS RUPTURED WHEN WATER WAS ENTERED. PER FOLLOW UP VIA EMAIL ON 26NOV2024, IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT OTHER THEN WASTED CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20343825 ↗
• MalfunctionMay 13, 2022Nonstandard Device; Component Misassembled; Nonstandard Device; Component Misassembled

  IT WAS REPORTED THAT THE IRRIGATION PORT OF THE FOLEY CATHETER BLEW UP THE BALLOON AND THE INFLATION PORT IRRIGATED THE BLADDER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14397899 ↗
• MalfunctionMar 31, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED ABOUT PAIN, BLADDER SPASMS AND LEAKAGE WHEN THEY WERE ASKED OF COMPLICATIONS WHILE USING THE HYDROGEL COATED PROSTATIC 3-WAY DUFOUR CATHETER. THE SURVEY RESPONDENT ALSO STATED THAT THE INSTRUCTIONS FOR USE (IFU) DID NOT PROVIDE SUFFICIENT INFORMATION BECAUSE IT WAS NOT AVAILABLE IN PACKAGING AT THE TIME. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13971196 ↗
• MalfunctionMar 31, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED PAIN, BLADDER SPASMS AND LEAKAGE WHEN THEY WERE ASKED ABOUT COMPLICATIONS WHILE USING THE HYDROGEL COATED PROSTATIC 3-WAY DUFOUR CATHETER. THE SURVEY RESPONDENT ALSO STATED THAT THE INSTRUCTIONS FOR USE (IFU) DID NOT PROVIDE SUFFICIENT INFORMATION BECAUSE IT WAS NOT AVAILABLE IN PACKAGING AT THE TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13967206 ↗
• MalfunctionNov 9, 2021Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE IRRIGATION PORT AND BALLOON PORT OF THE FOLEY CATHETER WAS SWITCHED. THE NURSE INSERTED THE CATHETER AND THEN INFLATED THE BALLOON THROUGH THE BALLOON PORT. BUT THE CATHETER CAME OUT AND IT WAS DISCOVERED THAT THE PORTS WERE REVERSED. SO, INSERTED A NEW CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12783387 ↗
• MalfunctionSep 28, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER FLUSH PORT WAS LEAKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12541198 ↗
• MalfunctionMay 28, 2021Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE 22 FR 30 CC RIBBED BALLOON HEMATURIA COUDE 3 WAY CONTINUOUS IRRIGATION CATHETER HAD AN UNKNOWN DEFECT. PER FOLLOW UP VIA EMAIL ON (B)(6) 2021 IT WAS STATED THAT THE PROBLEM EXPERIENCED WITH THE DEVICE WAS A HOLE IN THE CATHETER BALLOON. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11899345 ↗
• MalfunctionNov 19, 2020Inability to Irrigate; Inability to Irrigate

  IT WAS REPORTED THAT THE IRRIGATION PORT WAS NOT ABLE TO BE FLUSH. PER FOLLOW UP VIA EMAIL ON 03NOV2020, IT WAS INDICATED THAT THE CATHETER WILL NOT BE RETURNED AND CONFIRMED WITH THE PROVIDER THAT THERE WAS NO PATIENT HARM.

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

  MAUDE report 10871788 ↗
• MalfunctionOct 4, 2019Break

  IT WAS REPORTED THAT THE BALLOON OF THE PROBE BROKE. GIVEN THE EXPERIENCE OF THE UROLOGIST WHO HAD PLACED THE PROBE, THE COMPLAINANT DOES NOT THINK IT COULD BE A MISUSE OF THE DEVICE.

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

  MAUDE report 9155791 ↗
• MalfunctionMar 19, 2019Partial Blockage; Obstruction of Flow; Partial Blockage

  IT WAS REPORTED THAT THE TIP OF THE CATHETER WAS FOUND OBSTRUCTED/CLOGGED. IT WAS LATER REPORTED VIA EMAIL ON (B)(6) 2019 FROM THE INTERNATIONAL BUSINESS CENTER (IBC) REPRESENTATIVE, THE DEVICE WAS USED ON PATIENT.

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

  MAUDE report 8434009 ↗