Bardex® Lubricath® Foley Catheter Coude Tip 0100L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741017896), received between Jan 27, 2021 and Feb 23, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Nonstandard Device

  IT WAS REPORTED THAT PATIENT STATED THE VALVE IS NOT WORKING ON THE FOLEY CATHETER. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24422033 ↗
• MalfunctionFeb 20, 2026Inflation Problem

  THE PATIENT RECEIVED TWO DEFECTIVE FOLEY CATHETERS. THE BALLOON WOULDN'T INFLATE. PATIENT NOW HAS A URINARY TRACT INFECTION. HE HAS HAD THE SAME FOLEY IN FOR OVER A MONTH. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408245 ↗
• InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED TWO DEFECTIVE FOLEY CATHS. THE BALLOON WOULDN'T INFLATE. PATIENT NOW HAS A URINARY TRACT INFECTION. HE HAS HAD THE SAME FOLEY IN FOR OVER A MONTH. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.

  Patient problems: Urinary Tract Infection

  MAUDE report 24408237 ↗
• MalfunctionDec 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE LATEX FOLEY CATHETER DOES NOT BLOW-UP OR INFLATE CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717330 ↗
• MalfunctionJul 11, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED BY THE PATIENT THAT ONE OF THE VALVES ON THE FOLEY IS NOT WORKING. IT IS UNCLEAR IF TROUBLESHOOTING WAS PERFORMED OR LOT NUMBER REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22484263 ↗
• MalfunctionMay 6, 2024Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A REPORT OF AN INDWELLING CATHETER FOLEY FALLING OUT. THIS WAS ACTUALLY AN ISSUE IN PREVIOUS MONTHS AS WELL, BUT AT THE TIME THEY DID NOT SAVE ANY PRODUCT INFORMATION SO THEY COULD NOT DETERMINE IF THIS WAS HAPPENING WITH MEDLINE OR BARD PRODUCTS. ALTHOUGH THEY COULD NOT VERIFY THE PREVIOUS REPORTS WERE INVOLVING THE SAME SKUS, THEY DO WANT TO SEE IF THIS WAS COMING FROM A DEFECTIVE LOT OR PERHAPS A QUALITY ISSUE. THEY HAD THE FOLEY CATHETER AND BAG (SOILED) IN A BIOHAZARD BAG IN THEIR OFFICE IF IT NEEDS TO BE RETURNED FOR INVESTIGATION. PATIENT HAD CATHETER INSERTED IN THE OPERATING ROOM ON (B)(6) 2024 DURING A KIDNEY TRANSPLANT CASE, REPORTED FALLING OUT TODAY. THEY RECEIVED 4 REPORTS FROM PATIENT CARE UNITS THAT PATIENT¿S INDWELLING URINARY CATHETERS WERE FALLING OUT. IN THE MOST RECENT SITUATION, APPARENTLY THE PATIENT HEARD A POP AND THEN THE CATHETER CAME OUT. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 12APR2024, CUSTOMER HAD NOT HEARD OF ANOTHER INCIDENT SO HOPEFULLY THIS WAS JUST A DEFECTIVE RUN. THE LOT#NGFS3624 WAS THE ONLY LOT# THAT THEY HAVE CONFIRMED AS MENTIONED PREVIOUSLY THIS DID OCCUR A COUPLE TIMES BEFORE, BUT THE CLINI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248593 ↗
• MalfunctionApr 5, 2024Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A REPORT OF AN INDWELLING CATH FOLEY FALLING OUT. THIS WAS ACTUALLY AN ISSUE IN PREVIOUS MONTHS AS WELL, BUT AT THE TIME THEY DID NOT SAVE ANY PRODUCT INFORMATION SO THEY COULD NOT DETERMINE IF THIS WAS HAPPENING WITH MEDLINE OR BARD PRODUCTS. ALTHOUGH THEY COULD NOT VERIFY THE PREVIOUS REPORTS WERE INVOLVING THE SAME SKUS, THEY DO WANT TO SEE IF THIS WAS COMING FROM A DEFECTIVE LOT OR PERHAPS A QUALITY ISSUE. THEY HAD THE FOLEY CATHETER AND BAG (SOILED) IN A BIOHAZARD BAG IN THEIR OFFICE IF IT NEEDS TO BE RETURNED FOR INVESTIGATION. PATIENT HAD CATHETER INSERTED IN THE OPERATING ROOM ON (B)(6) 2024 DURING A KIDNEY TRANSPLANT CASE, REPORTED FALLING OUT TODAY. THEY RECEIVED 4 REPORTS FROM PATIENT CARE UNITS THAT PATIENT¿S INDWELLING URINARY CATHETERS WERE FALLING OUT. IN THE MOST RECENT SITUATION, APPARENTLY THE PATIENT HEARD A POP AND THEN THE CATHETER CAME OUT. PER FOLLOW UP RESPONSE RECEIVED VIA EMAIL ON 12APR2024, CUSTOMER HAD NOT HEARD OF ANOTHER INCIDENT SO HOPEFULLY THIS WAS JUST A DEFECTIVE RUN. LOT#NGFS3624 THIS WAS THE ONLY LOT# THAT THEY HAVE CONFIRMED AS MENTIONED PREVIOUSLY THIS DID OCCUR A COUPLE TIMES BEFORE, BUT THE CLINICIA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19049495 ↗
• MalfunctionApr 2, 2024Burst Container or Vessel; Material Rupture; Burst Container or Vessel; Material Rupture

  IT WAS REPORTED THAT THE CUSTOMER RECEIVED A REPORT OF AN INDWELLING CATH FOLEY FALLING OUT. THIS WAS ACTUALLY AN ISSUE IN PREVIOUS MONTHS AS WELL, BUT AT THE TIME THEY DID NOT SAVE ANY PRODUCT INFORMATION SO THEY COULD NOT DETERMINE IF THIS WAS HAPPENING WITH MEDLINE OR BARD PRODUCTS. ALTHOUGH THEY COULD NOT VERIFY THE PREVIOUS REPORTS WERE INVOLVING THE SAME SKUS, THEY DO WANT TO SEE IF THIS WAS COMING FROM A DEFECTIVE LOT OR PERHAPS A QUALITY ISSUE. THEY HAD THE FOLEY CATHETER AND BAG (SOILED) IN A BIOHAZARD BAG IN THEIR OFFICE IF IT NEEDS TO BE RETURNED FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19019608 ↗
• MalfunctionDec 8, 2023Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT WHEN THE PATIENT WENT TO THE DOCTOR TO HAVE THE FOLEY CATHETER CHANGED, IT WAS DIFFICULT TO REMOVE AND CAUSED BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.

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

  MAUDE report 18290338 ↗
• InjuryJan 27, 2021Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT COULD NOT USE THE FOLEY CATHETERS BECAUSE IT FELT AS THOUGH THEY RIP THROUGH THE COLON. IT IS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED.

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

  MAUDE report 11236767 ↗