Bardex I.C. Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 26 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3,607
- Deaths reported
- 0
- Injuries reported
- 257
- Recalls
- 0
We found 26 models of Bardex I.C. Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 3,607 adverse event reports in the FDA's MAUDE database, received between Mar 28, 2017 and Sep 30, 2026 — classified as 257 injuries, 3,350 malfunctions.
The most frequently reported specific device problem is “Failure to Infuse” (551 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 Bardex I.C. Foley Catheter problems
Device problems
- Failure to Infuse551
- Fluid/Blood Leak520
- Deflation Problem505
- Material Puncture/Hole487
- Decrease in Pressure368
- Burst Container or Vessel361
- Material Rupture268
- Inflation Problem260
Patient problems
- No Clinical Signs, Symptoms or Conditions2,399
- No Known Impact Or Consequence To Patient731
- No Consequences Or Impact To Patient616
- No Patient Involvement289
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available110
- Foreign Body In Patient107
- Patient Problem/Medical Problem69
- No Code Available34
Bardex I.C. Foley Catheter models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® I.C. Foley Catheter 0165SI14CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 reports
- Bardex® I.C. Foley Catheter 0165SI16CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® I.C. Foley Catheter 0165SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 reports
- Bardex® I.C. Foley Catheter 0165SI12CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES149 reports
- Bardex® I.C. Foley Catheter 0165SI20CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES81 reports
- Bardex® I.C. Foley Catheter 0165SI24CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES35 reports
- Bardex® I.C. Foley Catheter 0165SI22CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES19 reports
- Bardex® I.C. Foley Catheter 0166SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES13 reports
- Bardex® I.C. Foley Catheter 0166SI16CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES12 reports
- Bardex® I.C. Foley Catheter 0167SI22CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES12 reports
- Bardex® I.C. Foley Catheter 0167SI24CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES12 reports
- Bardex® I.C. Foley Catheter 0166SI24CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES10 reports
- Bardex® I.C. Foley Catheter 0166SI20CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES8 reports
- Bardex® I.C. Foley Catheter 1857SI22CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES5 reports
- Bardex® I.C. Foley Catheter 1857SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® I.C. Foley Catheter 0165SI28CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® I.C. Foley Catheter 0165SI30CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0166SI14CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0166SI22CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0166SI26CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0167SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0167SI20CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 1857SI24CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® I.C. Foley Catheter 0166SI30CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Bardex® I.C. Foley Catheter 0167SI16CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
- Bardex® I.C. Foley Catheter 0167SI26CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent Bardex I.C. Foley Catheter 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 50952605 ↗MalfunctionSep 30, 2026Disconnection
It was reported that the Foley catheter was leaking and discovered that the collection port was missing. The detached collection port was found on the patient absorbent pad.As per customer follow up information received on 08Sep2026, physical samples are available. There was no medical intervention required.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951862 ↗MalfunctionSep 30, 2026Fluid/Blood Leak
It was reported that Urine leaks from the space between the catheter and the urethra.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950581 ↗MalfunctionSep 29, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940874 ↗MalfunctionSep 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940871 ↗MalfunctionSep 29, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940505 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917213 ↗MalfunctionSep 25, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899366 ↗InjurySep 21, 2026Difficult to Remove
It was reported that during the catheter exchange, health professional confirmed that approximately 8 mL of retained fluid had been drained and attempted to remove the Foley catheter; however, it did not fall out. A Computed Tomography (CT) scan revealed that the balloon section contained no retained fluid but appeared to be filled with air. Therefore, following the troubleshooting protocol, health professional removed the catheter using the non-rupture method.It was also mentioned that health professional was present for the tube removal. There is residual air in the balloon section of the device. Based on the CT images taken prior to tube removal, it appears there was slightly more residual air at that time. Need to verify this. Since this patient was transferred from another hospital, the product code is believed to be 7760014LR.
Patient problems: Insufficient Information
MAUDE report 50841690 ↗MalfunctionSep 21, 2026Difficult to Remove
It was reported that the balloon was inserted on (b)(6) 2026. On (b)(6) 2026, when health professional attempted to remove the balloon, the sterile water did not fall out. When the health professional pumped to try to remove it, about 5 mL of water fell out, and the balloon was successfully removed by pulling on the catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50839599 ↗MalfunctionSep 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829597 ↗MalfunctionSep 18, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819870 ↗MalfunctionSep 18, 2026Material Puncture/Hole
It was reported that during use a balloon catheter was inserted during surgery on (b)(6). It came out spontaneously in the ward on (b)(6). Suspecting a malfunction, the foley catheter balloon was inflated and expanded without issue. There were no abnormalities for about three hours, but six hours later, the balloon had deflated. The area near the tip was wet.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819868 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809592 ↗InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem
It was reported that the Regular catheter was very uncomfortable and got infection. No medical intervention was reported.
Patient problems: Discomfort; Unspecified Infection
MAUDE report 50802928 ↗
Other C. R. Bard, Inc. products
- 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
- Bardia Foley Catheter Silicone Coated19 models · 1,283 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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