Bard® Lubricath® Foley Catheter 365724Recalls & reported problems

C. R. Bard, Inc. · Bard® Lubricath® Foley Catheter, 5cc Balloon Lubricious Coated · Class 2

All models of Bard Lubricath Foley Catheter (8)

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 00801741077784), received between Jan 7, 2020 and Jun 25, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Burst Container or Vessel1
Difficult to Remove1
Fluid/Blood Leak1
Material Protrusion/Extrusion1

Patient problems

No Clinical Signs, Symptoms or Conditions2
No Consequences Or Impact To Patient1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

MalfunctionJun 25, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT FOR 15 YEARS, THE USER HAD NO ISSUES USING A GREEN FOLEY CATHETER FROM THE COMPANY. RECENTLY, THEY RECEIVED A BROWN REPLACEMENT DUE TO SUPPLY ISSUES. AFTER ONE DAY, THE USER EXPERIENCED URINE AND FLUID LEAKAGE AND INFORMED THEIR MEDICAL TEAM. THE CATHETER WAS DIFFICULT AND PAINFUL TO REMOVE, WITH SMALL BUBBLES NOTED AT THE END.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22329805 ↗
MalfunctionJun 25, 2025Difficult to Remove; Material Protrusion/Extrusion; Difficult to Remove; Material Protrusion/Extrusion
IT WAS REPORTED THAT FOR 15 YEARS, THE USER HAD NO ISSUES USING A GREEN FOLEY CATHETER FROM THE COMPANY. RECENTLY, THEY RECEIVED A BROWN REPLACEMENT DUE TO SUPPLY ISSUES. AFTER ONE DAY, THE USER EXPERIENCED URINE AND FLUID LEAKAGE AND INFORMED THEIR MEDICAL TEAM. THE CATHETER WAS DIFFICULT AND PAINFUL TO REMOVE, WITH SMALL BUBBLES NOTED AT THE END. PER ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 10JUL2025, CUSTOMER STATED THEY ARE MAINTAINING THE CATHETER CURRENTLY IN A ZIPLOCK BAG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22328028 ↗
MalfunctionJan 7, 2020Burst Container or Vessel
IT WAS REPORTED THAT THE 24 INCH LONG FOLEY CATHETER WAS FILLED WITH 8CC OF WATER, AND THE BALLOON BURST INSIDE THE PATIENTS BLADDER DURING USAGE.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9558383 ↗

Device details

UDI-DI	`00801741077784`
Brand	Bard® Lubricath® Foley Catheter
Model	365724
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

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562 reports
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539 reports
Bardia® Foley Catheter Silicone Coated 123516A
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381 reports
Bardia® Foley Catheter Silicone Coated 123514A
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SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916
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Bardia® Foley Catheter Silicone Coated 123518A
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153 reports
SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916
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2 recalls50 reports
Bard® Lubricath® Foley Catheter 365716
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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.

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