Bardex® Lubricath® Foley Catheter Coude Tip 0168L22Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741017858), received between Jul 22, 2022 and Feb 20, 2026 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Inadequate or Insufficient Training” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 20, 2026Difficult to Remove

  PATIENT SAID THE FOLEY BALLOON DID NOT DEFLATE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24408236 ↗
• MalfunctionJun 26, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT PATIENT RECEIVED 2 OF THE FOLEY CATHETERS WERE DEFECTIVE, THE BALLOON WOULD NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22336710 ↗
• MalfunctionSep 5, 2023Decrease in Pressure; Decrease in Pressure

  IT WAS REPORTED THAT THE PATIENT STATED THAT URINE WAS INSIDE THE BALLOON, THE BALLOON DEFLATES, AND LEAKAGE OCCURS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682483 ↗
• MalfunctionJan 10, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO AND THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES AND INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL IN RELATION TO CARSON MODEL, LUBRICATH®, 2-WAY, 5CC BALLOON, FRENCH SIZE 22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129917 ↗
• MalfunctionJan 5, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD/BECTON DICKINSON PRODUCT(S) PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCT(S) AND ITS MEDICAL APPLICATION BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD LACK OF MAINTENANCE DOCUMENTATION OR GUIDELINES AND INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL IN RELATION TO CARSON MODEL, LUBRICATH, 2-WAY, 5CC BALLOON, FRENCH SIZE 22.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16101634 ↗
• MalfunctionJan 4, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training

  IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD/BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND ITS MEDICAL APPLICATION BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO BIOCATH FOLEY CATHETER PRECONNECTED TO A URINE METER, FEMALE LENGTH, NO FRENCH SIZE SPECIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094858 ↗
• MalfunctionJul 22, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON OF THE FOLEY CATHETER GOT LEAKED CAUSING CATHETERS TO COME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15085850 ↗