Bardex® Lubricath® Foley Catheter Coude Tip 0100L18Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741017889), received between Jun 5, 2018 and Mar 13, 2025 — classified as 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Component Misassembled” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT CUSTOMER SAID THE FOLEY CATHETER CAUSED PAIN. NO MEDICAL INTERVENTION WAS REPORTED. PER CUSTOMER FOLLOW UP VIA PHONE ON 20FEB2025, IT WAS REPORTED THAT THE CATHETER WAS THE WRONG SIZE FOR THE PATIENT, AND THEY SWITCHED TO A DIFFERENT CATHETER. NO FURTHER ISSUES REPORTED.

  Patient problems: Pain

  MAUDE report 21593426 ↗
• MalfunctionJan 7, 2025Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THEY RECEIVED A COMPLAINT OF A DEFECTIVE PRODUCT OF RIBBED BALLOON CATHETER. THE FOLEY CATHETER DID NOT HAVE A HOLE IN THE END, LEADING THE STAFF TO HAVE TO RE-CATHETER THE PATIENT. THERE WERE NO ADVERSE EVENTS RELATED TO THE DEFECTIVE PRODUCT OF USE. HOWEVER, THE USED THE PRODUCT WAS DISCARDED AND NOT RETAINED FOR THE COMPLAINT PROCESS. PER CUSTOMER VIA PHONE ON (B)(6)2025, IT WAS REPORTED THAT THE ITEM WAS THROWN AWAY. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21091643 ↗
• InjuryApr 11, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHEN USER WAS ASKED IF THEY EXPERIENCED COMPLICATIONS WHILE USING THE FOLEY CATHETER, USER STATED THAT THEY EXPERIENCED PAIN, HEMATURIA, INCONTINENCE, BLADDER FISTULA, URETHRAL OR BLADDER TRAUMA, BLADDER CANCER, BOWEL INJURY, BLADDER PERFORATION, URETHRAL SPHINCTER DYSFUNCTION, ACCIDENTAL REMOVAL AND RETAINED FRAGMENTS FROM CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 14077940 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA WHEN ASKED OF COMPLICATIONS WHILE USING FOLEY CATHETER. ALSO THE CATHETER WAS BLOCKAGE AND REMOVED ACCIDENTALLY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13973128 ↗
• InjuryApr 1, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE USER EXPERIENCED BACTERIURIA WHEN ASKED OF COMPLICATIONS WHILE USING FOLEY CATHETER. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 13972955 ↗
• InjuryApr 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURVEY RESPONDENT MENTIONED SYMPTOMATIC URINARY TRACT INFECTION, HEMATURIA WHEN ASKED ABOUT COMPLICATIONS WHILE USING THE FOLEY CATHETER. ALSO THE CATHETER WAS BLOCKED AND ACCIDENTALLY REMOVED WHILE USING . IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

  Patient problems: Hematuria; Urinary Tract Infection

  MAUDE report 13972544 ↗
• MalfunctionDec 22, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THE PATIENT NOTICED THERE WERE NO EYELETS ON THE CATHETER WHILE USING IT.

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

  MAUDE report 11060455 ↗
• MalfunctionDec 22, 2020Component Misassembled; Component Misassembled

  IT WAS REPORTED THAT THERE WAS NO EYELID ON THE CATHETER UPON OPENING THE PACKAGE BY THE PATIENT.

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

  MAUDE report 11059792 ↗
• MalfunctionNov 16, 2020Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE FOLEY HAS CLOGGED WITH A SEDIMENT OR CRYSTALLIZATION.

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

  MAUDE report 10844484 ↗
• MalfunctionJun 5, 2018Nonstandard Device; Device Operates Differently Than Expected; Nonstandard Device

  IT WAS REPORTED THAT THE FOLEY CATHETER FELT STIFFER THAN USUAL. NO PATIENT INJURY REPORTED AND NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 7569096 ↗
• MalfunctionJun 5, 2018Insufficient Device Problem Information

  IT WAS REPORTED THAT THE TIP OF THE FOLEY CATHETER WAS CURVED, AND ALLEGEDLY CAUSED SELF-LIMITED BLEEDING UPON INSERTION. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7569095 ↗
• MalfunctionJun 5, 2018Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT NOTICED URINE LEAKING FROM HER URETHRA A FEW HOURS AFTER INSERTION OF THE FOLEY CATHETER. NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 7569086 ↗
• MalfunctionJun 5, 2018Misassembled; Positioning Problem; Misassembled

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER WAS APPROXIMATELY 1/4 INCH CLOSER TO THE TIP OF THE CATHETER THAN USUAL. NO MEDICAL INTERVENTION REQUIRED.

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

  MAUDE report 7569085 ↗