Bardex® Lubri-Sil® All-Silicone Foley Catheter 176820Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubri-Sil® All Silicone Lubricious Coated 30 cc Foley Catheter · Class 2
All models of Bardex Lubri-Sil All-Silicone Foley Catheter (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741034237), received between Mar 17, 2022 and Mar 29, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (3 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.
Most reported problems
Device problems
- Decrease in Pressure3
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 29, 2022Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER FELL OUT OF THE PATIENT WHO WAS BED BOUND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13943918 ↗MalfunctionMar 18, 2022Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE SILICONE FOLEY CATHETER FELL OUT OF A BEDBOUND PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13804432 ↗MalfunctionMar 17, 2022Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE FOLEY CATHETER FELL OUT. THE FOLEY CATHETER WAS INSERTED ON (B)(6) 2022 AND IT FELL OUT OF THE PATIENT ON (B)(6) 2022 WHILE ON A WALK. WHEN THE CATHETER WAS CHECKED, THE BALLOON WAS FOUND TO BE DEFLATED AND ONLY 2CC OF WATER WAS LEFT IN THE 30CC BALLOON. A NEW CATHETER WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13792222 ↗
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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