Bardex® Lubri-Sil® All-Silicone Temp Sensing Foley Catheter 119210MRecalls & reported problems
C. R. Bard, Inc. · Bardex® Lubri-Sil® 400 Series Temperature Sensing All-Silicone 3 cc Foley Catheter · Class 2
All models of Bardex Lubri-Sil All-Silicone Temp Sensing Foley Catheter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741046278), received between Sep 16, 2022 and Sep 27, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 27, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE NURSE PLACED FOLEY IN THE PATIENT AND FOLEY BEGAN TO LEAK FROM SILICONE WHERE TEMPERATURE PROBE INSERTED INTO IT, AT JUNCTION. THEY HAD TO REMOVE FOLEY AND PLACE A NEW ONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20321779 ↗MalfunctionSep 16, 2022Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE TEMPERATURE SENSING FOLEY CATHETER WAS TOTALLY BLOCKED. STATED THAT IT WAS PUT INTO THE PATIENT BUT DID NOT GET ANY URINE BACK AND COULD NOT BE FLUSHED. REMOVED FROM PATIENT, ATTEMPTED TO FLUSH AGAIN, BUT COULD NOT BE FLUSHED. AND STATED THAT THE FAULTY FOLEY CATHETER REMOVED AND NEW ONE INSTALLED WITH NO ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15437820 ↗
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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