Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L20Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741018145), received between Sep 6, 2018 and Sep 17, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• InjurySep 17, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ASSISTED URETEROSCOPY, LEFT FLEXIBLE URETEROSCOPY, LASER OF IMPACTED STONE ABOUT THE L2 LEVEL OF THE LEFT URETER, LASER OF BLADDER STONES, RETRIEVAL OF FRAGMENT OF LEFT SAFETY WIRE AND LEFT STENT PLACEMENT #24 X 6-FRENCH JJ STENT. AT THE CONCLUSION OF THE PROCEDURE THE DOCTOR PASSED "AN 18 F CUADE TIP (FOLEY) CATHETER AND THE EFFLUX WAS ONLY BLOOD TINGED." POST OP ORDERS INCLUDED FOLEY CATHETER HAND IRRIGATION Q 4HRS PRN [AS NEEDED] FOR HEMATURIA WITH NORMAL SALINE. ON POD [POST OPERATIVE DAY] #1, WHEN NURSE WENT TO IRRIGATE THE FOLEY CATHETER A POP OCCURRED. THE PROVIDER WAS IMMEDIATELY NOTIFIED AND ORDERS TO REPLACE THE FOLEY WAS GIVEN. THE FOLEY WAS REPLACED WITHOUT INCIDENT. A RENAL AND BLADDER US [ULTRASOUND] WAS PERFORMED WITH AN IMPRESSION OF NO HYDRONEPHROSIS, EMPTY BLADDER WITH FOLEY CATHETER IN PLACE, LEFT-SIDED NEPHROSTOMY CATHETER NON-OBSTRUCTING STONES RIGHT AND LEFT KIDNEY. IT WAS UNKNOWN THE CC OF SALINE USED TO FILL THE BALLOON AT THE TIME OF INSERTION BY THE PROVIDER.

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

  MAUDE report 23073669 ↗
• MalfunctionMar 19, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THERE WAS A HOLE WHILE THE USER TRIED TO INFLATE THE BALLOON OF THE FOLEY CATHETER. THEY COULD NOT PRE-FILL THE BALLOON NORMALLY AS PER THE PRACTICE GUIDELINES. HOWEVER, A MICRO TEAR WAS NOTED IN THE LAST PRODUCT THEY USED, SO THEY WANTED TO TEST IT, AND UPON CHECKING, THERE WAS A HOLE IN THE CURRENT PRODUCT THEY WERE USING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933126 ↗
• MalfunctionFeb 15, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOLEY CATHETER WAS LEAKING AND IT CAUSED THEIR PENIS TO BE RED AND IRRITATED. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 16379139 ↗
• MalfunctionNov 5, 2019Burst Container or Vessel; Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PATIENT SNEEZED AND THE BALLOON BURST. NO MEDICAL INTERVENTION WAS REQUIRED.

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

  MAUDE report 9280927 ↗
• MalfunctionAug 14, 2019Deflation Problem; Fluid/Blood Leak; Inflation Problem; Deflation Problem

  IT WAS REPORTED THAT A NURSE PLACED A FOLEY CATHETER IN THE PATIENT FOR NEO BLADDER DECOMPRESSION UPON ADMISSION TO THE HOSPITAL. THE NURSE INSTILLED 10CC OF STERILE WATER INTO THE BALLOON, DURING WHICH TIME THERE WAS LEAKAGE OF SOME WATER FROM THE BALLOON PORT TUBING ABOUT HALF WAY FROM THE HUB TO THE INSERTION OF THE CATHETER. THE CUSTOMER ALLEGES THE BALLOON APPEARS TO HAVE BEEN PARTIALLY INFLATED AND CURRENTLY REMAINS IN PLACE. HOWEVER, THERE IS A HIGHER RISK OF BECOMING DISLODGED IN WHICH CASE A NEW CATHETER WILL HAVE TO BE PLACED.

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

  MAUDE report 8892419 ↗
• MalfunctionMay 30, 2019Break; Break; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON OF THE LUBRICATH COUDE FOLEY CATHETER HAD HOLES IN IT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654134 ↗
• MalfunctionSep 6, 2018Fluid/Blood Leak; Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE FOLEY CATHETER LEAKED URINE AROUND THE MEATUS IMMEDIATELY AFTER PLACEMENT.

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

  MAUDE report 7853890 ↗