Bardia 123520CERecalls & reported problems

C. R. Bard, Inc. · Bardia Silicone Elastomer Coated Foley Catheter · Class 2

All models of Bardia (11)

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741171703), received between Jun 3, 2026 and Jun 3, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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

Device Contamination with Chemical or Other Material1
Fungus in Device Environment1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 3, 2026Fungus in Device Environment; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE TRIAL SAMPLE WAS TESTED USING TGC BROTH CULTURE FOR 14 DAYS, AND FUNGAL GROWTH WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382751 ↗

Device details

UDI-DI	`00801741171703`
Brand	Bardia
Model	123520CE
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	Aug 29, 2023

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
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562 reports
Bardex® Lubricath® Foley Catheter 0165L16
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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.

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