Bardex® All-Silicone Temperature-Sensing Foley Catheter 119114Recalls & reported problems
C. R. Bard, Inc. · Bardex® All-Silicone Temperature-Sensing Foley Catheter · Class 2
All models of Bardex All-Silicone Temperature-Sensing Foley Catheter (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741046025), received between May 9, 2019 and Mar 16, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 Rupture2
- Deflation Problem1
- Fluid/Blood Leak1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Exposure to Body Fluids1
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 16, 2026Material Rupture
IT WAS REPORTED THAT BALLOON RUPTURE OF THE FOLEY CATHETER DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24612392 ↗MalfunctionSep 25, 2025Material Puncture/Hole; Material Split, Cut or Torn; Material Puncture/Hole; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING USE, FOLEY CATHETER LEAKED AT Y DOWN STRAIGHT. PATIENT WAS EXPOSED TO URINE. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Exposure to Body Fluids
MAUDE report 23145090 ↗MalfunctionSep 15, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE CLIENT COMPLAINED THAT JUST MINUTES AFTER INSTALLING THE FOLEY CATHETER WITH A TEMPERATURE SENSOR, IT BEGAN LEAKING URINE. IT WAS CONSIDERED BROKEN. THE CATHETER WAS REPLACED, AND THE PATIENT WAS ABLE TO CONTINUE THEIR NORMOTHERMIA THERAPY. PATIENT'S NORMOTHERMIA THERAPY WAS DELAYED AND INTERRUPTED FOR A FEW MINUTES.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 23051336 ↗MalfunctionMay 9, 2019Deflation Problem; Material Rupture; Deflation Problem
IT WAS REPORTED THAT THE BALLOON RUPTURED. THE BALLOON WAS INFUSED WITH WATER UNDER 10CC.
Patient problems: No Consequences Or Impact To Patient; No Information
MAUDE report 8594693 ↗
Other CATHETER, RETENTION TYPE, BALLOON devices
- Bardex® All-Silicone Foley Catheter 165816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175816C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON476 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON234 reports
- Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119216MC. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON167 reports
- Bardex® Lubri-Sil® All-Silicone Foley Catheter 175814C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON153 reports
- Bardex® All-Silicone Foley Catheter 165812C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON151 reports
- SureStep™ Foley Tray System Bard® Lubri-Sil® Foley Catheter Tray A942216C. R. Bard, Inc. · CATHETER, RETENTION TYPE, BALLOON2 recalls46 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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