Bardex® I.C. Temperature Sensing Foley Catheter 129414MRecalls & reported problems
C. R. Bard, Inc. · Bardex® I.C. Temperature Sensing Foley Catheter 5cc Balloon · Class 2
All models of Bardex I.C. Temperature Sensing Foley Catheter (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard Bardex I.C. temperature-sensing Foley catheter is a urinary catheter with a temperature probe. Its 406 adverse event reports often describe holes or cracks in the catheter, balloon deflation problems, and the temperature sensor not working. A few describe a burn from its lead wire and severe pain on removal. The reports include no deaths and 9 injuries. No recalls name this device. Reports fell from 248 in the earlier year to 58 in the latest year.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 436
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 436 adverse event reports that list this exact device (DI 00801741046322), received between Apr 20, 2017 and Sep 30, 2026 — classified as 10 injuries, 426 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (113 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, 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
Most reported problems
Device problems
- Material Puncture/Hole113
- Deflation Problem94
- Material Rupture40
- No Display/Image40
- Difficult to Remove21
- Fluid/Blood Leak21
- Inflation Problem21
- Inaccurate Flow Rate16
Patient problems
- No Clinical Signs, Symptoms or Conditions403
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Discomfort9
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient4
- Urinary Retention4
- Genital Bleeding2
- Pain2
Recent adverse event reports
The 25 most recent of 436 reports, 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 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 ↗MalfunctionSep 6, 2026Erratic or Intermittent Display
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50636818 ↗MalfunctionSep 4, 2026Material Rupture
It was reported that during use, a message from the ICU. The patient experienced urinary leakage, and upon examination, the foley catheter balloon was found to be ruptured.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50616652 ↗MalfunctionSep 2, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50567751 ↗MalfunctionAug 24, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420783 ↗MalfunctionAug 22, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50391879 ↗MalfunctionAug 18, 2026No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303794 ↗InjuryAug 17, 2026Use of Device Problem
It was reported that an MRI was implemented on a patient undergoing placement while the lead wire was inside the patient¿s diaper, resulting in a burn near the left buttock. The package insert was reviewed, and the hospital acknowledges that this was not the proper method of use. It is reported that the lead wire did not trigger the metal detector during the MRI implementation. As a treatment, a covering material (Aquacel AG) was being used.
Patient problems: Burn(s)
MAUDE report 50280948 ↗MalfunctionAug 3, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50124257 ↗MalfunctionJul 30, 2026Material Puncture/Hole
It was reported that after being placed, the Foley catheter balloon deflated and came out on its own. Upon checking the balloon, there was a water leak.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50089790 ↗MalfunctionJul 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084500 ↗MalfunctionJul 30, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50084499 ↗MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50039127 ↗
Other CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES devices
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119314C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 recall3,889 reports
- Bardex® I.C. Foley Catheter 0165SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,994 reports
- Bardex® I.C. Foley Catheter 0165SI16C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1,052 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Temp Sensing Foley Catheter 119316MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES231 reports
- Bardex® Lubri-Sil® I.C. Temperature-Sensing All-Silicone Foley Catheter 119316C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES198 reports
- Bardex® I.C. Foley Catheter 0165SI18C. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES181 reports
- SureStep™ Foley Tray System Bardex® I.C. Complete Care Foley Catheter A319416AMC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 recalls18 reports
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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