Bardex I.C. Temperature Sensing Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 614
- Deaths reported
- 0
- Injuries reported
- 24
- Recalls
- 0
We found 4 models of Bardex I.C. Temperature Sensing Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 614 adverse event reports in the FDA's MAUDE database, received between Apr 20, 2017 and Sep 30, 2026 — classified as 24 injuries, 590 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (126 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. Temperature Sensing Foley Catheter problems
Device problems
- Material Puncture/Hole126
- Deflation Problem101
- Erratic or Intermittent Display47
- No Display/Image47
- Inaccurate Flow Rate45
- Material Rupture45
- Fluid/Blood Leak38
- Difficult to Remove27
Patient problems
- No Clinical Signs, Symptoms or Conditions526
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available17
- Discomfort14
- Pain7
- Urinary Retention7
- Urinary Tract Infection5
Bardex I.C. Temperature Sensing Foley Catheter models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® I.C. Temperature Sensing Foley Catheter 129414MCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 reports
- Bardex® I.C. Temperature Sensing Foley Catheter 129416MCATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES168 reports
- Bardex® I.C. Temperature-Sensing Foley Catheter 129416CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES8 reports
- Bardex® I.C. Temperature-Sensing Foley Catheter 129414CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
Recent Bardex I.C. Temperature Sensing 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, 2026Inflation Problem
It was reported that health professional inserted the Foley catheter and filled the balloon with water, but the cuff did not inflate and felt resistance. After removing the catheter and refilling it, was able to inflate the balloon. Health professional chose not to use it because was concerned.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950587 ↗MalfunctionSep 24, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889825 ↗InjurySep 21, 2026Material Puncture/Hole
Patient problems: Genital Bleeding
MAUDE report 50848288 ↗MalfunctionSep 18, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829609 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809591 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809423 ↗MalfunctionSep 17, 2026Material Puncture/Hole
It was reported that on (b)(6) 2026, a catheter was inserted for heart surgery. Upon leaving the operating room, urine output was confirmed, and the urine in the collection bag was discarded. In the evening, it was confirmed in the Intensive Care Unit (ICU) that there was no urine being produced. When the catheter was removed, the balloon was not inflated; assuming this might have made it difficult to locate the catheter, a fixed volume solution was infused. Since there was no urine produced afterward, the catheter was exchanged, resulting in the discharge of a large volume of urine mixed with blood. Urine output is currently confirmed to be normal.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50806116 ↗MalfunctionSep 17, 2026Material Puncture/Hole
It was reported that the Foley catheter spontaneously dislodged a few days after placement in the EICU.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802946 ↗MalfunctionSep 15, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781991 ↗MalfunctionSep 14, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765278 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765261 ↗MalfunctionSep 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50743256 ↗MalfunctionSep 11, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736925 ↗MalfunctionSep 11, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50736920 ↗MalfunctionSep 9, 2026Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50693908 ↗
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
- 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
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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