Bardia Foley Catheter Silicone CoatedRecalls & reported problems across all models
C. R. Bard, Inc. · 19 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,283
- Deaths reported
- 0
- Injuries reported
- 159
- Recalls
- 0
We found 19 models of Bardia Foley Catheter Silicone Coated by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,283 adverse event reports in the FDA's MAUDE database, received between Apr 18, 2017 and Sep 30, 2026 — classified as 159 injuries, 1,124 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (178 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardia Foley Catheter Silicone Coated problems
Device problems
- Material Rupture178
- Burst Container or Vessel148
- Difficult to Remove132
- Partial Blockage115
- Deflation Problem112
- Material Puncture/Hole93
- Fluid/Blood Leak81
- Failure to Infuse69
Patient problems
- No Clinical Signs, Symptoms or Conditions639
- No Consequences Or Impact To Patient352
- No Known Impact Or Consequence To Patient248
- Urinary Tract Infection56
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available51
- Pain45
- No Patient Involvement42
- Patient Problem/Medical Problem31
Bardia Foley Catheter Silicone Coated models
19 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardia® Foley Catheter Silicone Coated 123516ACATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514ACATHETER, COUDE195 reports
- Bardia® Foley Catheter Silicone Coated 123518ACATHETER, COUDE153 reports
- Bardia® Foley Catheter Silicone Coated 123616ACATHETER, UROLOGICAL126 reports
- Bardia® Foley Catheter Silicone Coated 123520ACATHETER, COUDE94 reports
- Bardia® Foley Catheter Silicone Coated 123614ACATHETER, UROLOGICAL75 reports
- Bardia® Foley Catheter Silicone Coated 123618ACATHETER, UROLOGICAL66 reports
- Bardia® Foley Catheter Silicone Coated 123524ACATHETER, COUDE42 reports
- Bardia® Foley Catheter Silicone Coated 123620ACATHETER, UROLOGICAL35 reports
- Bardia® Foley Catheter Silicone Coated 123512ACATHETER, COUDE26 reports
- Bardia® Foley Catheter Silicone Coated 123522ACATHETER, COUDE26 reports
- Bardia® Foley Catheter Silicone Coated 123622ACATHETER, UROLOGICAL19 reports
- Bardia® Foley Catheter Silicone Coated 123526ACATHETER, COUDE12 reports
- Bardia® Foley Catheter Silicone Coated 123624ACATHETER, UROLOGICAL12 reports
- Bardia® Foley Catheter Silicone Coated 123612ACATHETER, UROLOGICAL7 reports
- Bardia® Foley Catheter Silicone Coated 123626ACATHETER, UROLOGICAL6 reports
- Bardia® Foley Catheter Silicone Coated 123528ACATHETER, COUDE5 reports
- Bardia® Foley Catheter Silicone Coated 123628ACATHETER, UROLOGICAL2 reports
- Bardia® Foley Catheter Silicone Coated 123530ACATHETER, COUDE1 report
Recent Bardia Foley Catheter Silicone Coated adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952604 ↗MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940520 ↗MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940508 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926181 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926180 ↗InjurySep 28, 2026Difficult to Remove
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50923641 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Insufficient Information
MAUDE report 50922159 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Discomfort
MAUDE report 50916289 ↗InjurySep 28, 2026Inaccurate Flow Rate; Difficult to Remove
It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. (Batch#MYLQ3401), (Batch#MYKZ3880). Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient, they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate. Patient 1 Batch# MYKZ3880. Batch# MYLQ3401.Patient 2 Batch# MYKZ3880. Batch# MYLQ3401.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 50916288 ↗InjurySep 28, 2026Difficult to Remove
It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. (Batch#MYLQ3401, (Batch#MYKZ3880). Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient, they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate. Patient 1: Batch# MYKZ3880. Batch# MYLQ3401.Patient 2: Batch# MYKZ3880. Batch# MYLQ3401.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50916285 ↗InjurySep 25, 2026Inaccurate Flow Rate; Difficult to Remove
It was reported that they have not been able to identify specifically which of the sizes is causing problems. Initially, the issues were vague; it was felt that the emptying/flow of urine from the bladder was not functioning satisfactorily. Repeated flushing was required, even though the urine did not appear cloudy or in any way likely to cause a blockage. On several occasions, it became necessary to replace the catheter. On two occasions, involving two different patients, it was not possible to deflate the balloon when the catheter was to be removed. To remove this catheter from the patient. they cut it at the branching point, just behind where the balloon syringe is attached. This caused the ¿balloon¿ inside the bladder, which serves as fixation, to deflate.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50899363 ↗MalfunctionSep 22, 2026Component Misassembled
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50858520 ↗InjurySep 18, 2026Restricted Flow rate
Patient problems: Insufficient Information
MAUDE report 50828910 ↗MalfunctionSep 18, 2026Restricted Flow rate
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828900 ↗MalfunctionSep 15, 2026Patient Device Interaction Problem
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50782013 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
- PureWick Urine Collection System3 models · 1,096 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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