Bardex® Lubricath® Foley Catheter Coude Tip 0168L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741017841), received between May 31, 2017 and Jan 2, 2026 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (4 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2026Difficult to Remove

  IT WAS REPORTED THAT DURING USE IT BECAME A DIFFICULT REMOVAL CASE OF THE FOLEY CATHETER AS RESISTANCE WAS FELT DURING REMOVAL, AND ALTHOUGH WATER WAS WITHDRAWN BY RECONNECTING THE SYRINGE, THE BALLOON DID NOT FULLY DEFLATE. THE REMOVAL WAS CARRIED OUT WITH SOME RESISTANCE, BUT IT WAS SUCCESSFULLY TAKEN OUT FROM THE PATIENT'S BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23951063 ↗
• MalfunctionJun 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT FOLEY CATHETER DID NOT INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22231142 ↗
• MalfunctionJan 16, 2025Material Invagination; Device Dislodged or Dislocated; Material Invagination; Device Dislodged or Dislocated

  IT WAS REPORTED THAT WHILE ATTEMPTING TO CATHETERIZE A PATIENT AND AFTER A LOT OF MANIPULATION AND ATTEMPTS FOLEY CATHETER WAS REMOVED. AFTER REMOVAL THE STAFF NOTICED THAT, ALTHOUGH THE RETENTION BALLOON HAD BEEN DEFLATED, IT WAS STILL PARTIALLY INFLATED. ATTEMPTING TO CONTINUE TO DEFLATE THE BALLOON AFTER REMOVAL, IT WOULD NOT REDUCE IN SIZE. THIS LED TO INCREASED PAIN FOR THE PATIENT. PATIENT WAS CURRENTLY STABLE. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21168094 ↗
• MalfunctionDec 30, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT A REGISTERED NURSE AND UROLOGIST WERE ATTEMPTING TO CATHETERIZE A PATIENT WITH A 20F FOLEY CATHETER. AFTER A LOT OF MANIPULATION AND ATTEMPTS IT WAS REMOVED. AFTER REMOVAL THE STAFF NOTICED THAT, ALTHOUGH THE RETENTION BALLOON HAD BEEN DEFLATED, IT WAS STILL PARTIALLY INFLATED. ATTEMPTING TO CONTINUE TO DEFLATE THE BALLOON AFTER REMOVAL, IT WOULD NOT REDUCE IN SIZE. THIS LED TO INCREASED PAIN FOR THE PATIENT, SO THEY WANTED TO KNOW ABOUT THIS FOR THE EXISTING 20F COUDE CATHETERS IN SUPPLY. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Pain

  MAUDE report 21034560 ↗
• 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/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 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16129915 ↗
• MalfunctionJan 4, 2023Inadequate Instructions for Healthcare Professional; Inadequate or Insufficient Training; Inadequate Instructions for Healthcare Professional; 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/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 20.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094855 ↗
• InjuryDec 22, 2021Inaccurate Flow Rate; Adverse Event Without Identified Device or Use Problem; Inaccurate Flow Rate; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS USING THE FOLEY CATHETER AND IT WAS NO LONGER ALLOWING THE URINE TO FLOW. THE PATIENT HAD BEEN USING CATHETERS FOR MORE THAN 90 DAYS. PER ADDITIONAL INFORMATION RECEIVED ON 06DEC2021, IT WAS REPORTED THAT THE FOLEY CATHETER WAS DEFECTIVE AND NOT ALLOWING URINE TO FLOW INTO THE DRAIN BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13059938 ↗
• MalfunctionAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE 16FR COUDE CATHETER WAS DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268226 ↗
• MalfunctionAug 17, 2020Fluid/Blood Leak; Decrease in Pressure; Device Slipped; Decrease in Pressure

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETER WOULD NOT WORK, LEAKED AND SLIPPED OUT.

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

  MAUDE report 10417671 ↗
• MalfunctionAug 17, 2020Fluid/Blood Leak; Device Slipped

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETER WOULD NOT WORK, LEAKED AND SLIPPED OUT.

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

  MAUDE report 10417593 ↗
• MalfunctionAug 17, 2020Leak/Splash; Decrease in Pressure; Device Slipped; Decrease in Pressure

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETER WOULD NOT WORK, LEAKED AND SLIPPED OUT.

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

  MAUDE report 10417254 ↗
• MalfunctionAug 17, 2020Fluid/Blood Leak; Leak/Splash; Device Fell; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TWO OF THE FOLEY CATHETER WOULD NOT WORK, LEAKED AND SLIPPED OUT.

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

  MAUDE report 10416769 ↗
• MalfunctionFeb 26, 2018Leak/Splash; Device Slipped

  IT WAS REPORTED THAT THE CATHETER WAS LEAKING SALINE FROM INSIDE OF THE URETHRA, WHICH CAUSED THE CATHETER TO FALL OUT. THE CATHETER WAS IN PLACE FOR 30 DAYS WHEN THE LEAK WAS NOTICED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7298102 ↗
• MalfunctionJan 22, 2018Break; Hole In Material; Leak/Splash; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE BALLOON PORT TUBE HAD A TINY HOLE, AND WHEN THE DOCTOR ATTEMPTED TO INFLATE THE BALLOON, WATER SQUIRTED OUT OF THE HOLE. THE CATHETER WAS REMOVED IN TACT WITH NO MISSING PIECES. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 7210753 ↗
• InjuryNov 13, 2017Burst Container or Vessel; Material Fragmentation

  IT WAS REPORTED THAT THE CATHETER BALLOON BURST WITHIN THE PATIENT AND PIECES WERE MISSING. A CYSTOSCOPY WAS PERFORMED TO RETRIEVE THE PIECES.

  Patient problems: Foreign Body In Patient

  MAUDE report 7024269 ↗
• MalfunctionMay 31, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT THE CATHETER LEAKED WATER NEAR THE INFLATION VALVE WHILE THE USER INJECTED THE WATER INTO THE BALLOON.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6600924 ↗