Bardex® Lubricath® Foley Catheter 0119L22Recalls & reported problems

C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter Short Tip 3 Way Continuous Irrigation 5cc Balloon Lubricious Coated · Class 2

All models of Bardex Lubricath Foley Catheter (38)

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

Adverse event reports: 5
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741019081), received between Oct 24, 2017 and Dec 24, 2025 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (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

Deflation Problem1
Hole In Material1
Inability to Irrigate1
Inflation Problem1
Material Invagination1
Material Puncture/Hole1
Material Rupture1

Patient problems

No Clinical Signs, Symptoms or Conditions4
No Code Available1

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

MalfunctionDec 24, 2025Material Rupture; Material Rupture
IT WAS REPORTED THAT THIS WAS AN INCIDENT OF SPONTANEOUS CATHETER DISLODGEMENT. A 3-WAY 22FR FOLEY CATHETER WAS PLACED FOR A PATIENT WITH A THROMBUS. IT HAD SPONTANEOUSLY DISLODGED AFTER THREE DAYS. IT WAS UNCLEAR WHETHER IT CAME OUT DUE TO STERILE WATER LEAKAGE OR IF IT BURST AFTER BEING REMOVED WHILE THE BALLOON WAS INFLATED. THE ACTUAL DEVICE HAS BEEN DISCARDED AND COULD NOT BE VERIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23889528 ↗
MalfunctionMay 19, 2025Inflation Problem; Inability to Irrigate; Inflation Problem; Inability to Irrigate
IT WAS REPORTED THAT THE PHYSICIAN WAS TRIED TO INJECT STERILE WATER WITH A SYRINGE, BUT THE SYRINGE WAS NOT USED AS THE WATER DID NOT GO IN THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22045123 ↗
MalfunctionNov 15, 2024Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER WAS SPONTANEOUS DRAINED THE DAY AFTER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20694214 ↗
MalfunctionAug 25, 2023Material Invagination; Material Invagination
IT WAS REPORTED THAT THE BALLOON WAS RIDGED WHEN THE FOLEY CATHETER CATHETER WAS REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17624568 ↗
MalfunctionOct 24, 2017Deflation Problem; Hole In Material
IT WAS REPORTED THAT THE FOLEY CATHETER HAD A PINHOLE IN THE BALLOON, THEREFORE THE CATHETER BALLOON DEFLATED AFTER BEING INSERTED INTO THE PATIENT.
Patient problems: No Code Available
MAUDE report 6973287 ↗

Device details

UDI-DI	`00801741019081`
Brand	Bardex® Lubricath® Foley Catheter
Model	0119L22
Company	C. R. Bard, Inc.
Product code	EZC · CATHETER, COUDE
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.

Other CATHETER, COUDE devices

Bardex® Lubricath® Foley Catheter 0165L14
C. R. Bard, Inc. · CATHETER, COUDE
562 reports
Bardex® Lubricath® Foley Catheter 0165L16
C. R. Bard, Inc. · CATHETER, COUDE
539 reports
Bardia® Foley Catheter Silicone Coated 123516A
C. R. Bard, Inc. · CATHETER, COUDE
381 reports
Bardia® Foley Catheter Silicone Coated 123514A
C. R. Bard, Inc. · CATHETER, COUDE
195 reports
SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916
C. R. Bard, Inc. · CATHETER, COUDE
3 recalls19 reports
Bardia® Foley Catheter Silicone Coated 123518A
C. R. Bard, Inc. · CATHETER, COUDE
153 reports
SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916
C. R. Bard, Inc. · CATHETER, COUDE
2 recalls50 reports
Bard® Lubricath® Foley Catheter 365716
C. R. Bard, Inc. · CATHETER, COUDE
117 reports

All CATHETER, COUDE 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.

How reports and recalls are matched · Editorial policy · Report an error on this page