Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L18Recalls & reported problems

C. R. Bard, Inc. · Bardex® Lubricath® Tiemann Model Foley Catheter Coude Tip 30cc Balloon Red Latex Radiopaque Lubricious Coated · Class 2

All models of Bardex Lubricath Foley Catheter Tiemann Model Coude (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741018190), received between Oct 3, 2017 and Dec 4, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).

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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Deformation Due to Compressive Stress1
Device Operates Differently Than Expected1
Difficult to Remove1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Patient Involvement1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 4, 2024Difficult to Remove; Difficult to Remove
IT WAS REPORTED THAT THE FOLEY CATHETER WAS INSERTED INTO THE RECTUM FOR PR VANCO ADMINISTRATION AND THE BALLOON DIRECTIONS FILLED WITH 30CC AS PER DIRECTIONS ON THE PACKAGE. LEFT IN THE RECTUM FOR 1 HOUR. BALLOON DEFLATION WAS ATTEMPTED AND UNSUCCESSFUL WITH 10ML,20ML AND 60ML SYRINGES AND UNABLE TO DEFLATE THE BALLOON AND GENTLE TUGGING, USED TO REMOVE THE FOLEY, BALLOON INTACT. THIS EVENT HAPPENED ON THE 2ND SHIFT. UNABLE TO DEFLATE 2 FOLEYS IN THE RECTUM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20844423 ↗
MalfunctionFeb 23, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, PATIENT DID NOT AGREE THAT THE BENEFITS OF USING THE BARD/BECTON DICKINSON BIOCATH PRODUCT OUTWEIGH THE POTENTIAL RISKS BECAUSE IT MIGHT GET IN A KNOT IN RELATION TO TIEMANN MODEL, LUBRICATH, 2-WAY, 30CC BALLOON, FRENCH SIZE 18.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16426575 ↗
MalfunctionOct 3, 2017Device Operates Differently Than Expected
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER MUSHROOMED DURING PRETESTING.
Patient problems: No Patient Involvement
MAUDE report 6911884 ↗

Device details

UDI-DI	`00801741018190`
Brand	Bardex® Lubricath® Foley Catheter Tiemann Model Coude
Model	0103L18
Company	C. R. Bard, Inc.
Product code	KOD · CATHETER, UROLOGICAL
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 4, 2020

Device type (GMDN): Indwelling urethral drainage balloon catheter, non-antimicrobial

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

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All CATHETER, UROLOGICAL devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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