Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI18Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. All-Silicone Coated 30 cc Foley Catheter · Class 2
All models of Bardex Lubri-Sil I.C. All-Silicone Foley Catheter (26)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741025280), received between May 23, 2018 and Nov 27, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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
- Leak/Splash1
- Patient Device Interaction Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
- Sepsis1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 27, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
CRITICAL CARE NURSES IN AN ONLINE SURVEY REPORTED THAT THE PATIENT EXPERIENCED, AND ADVERSE EVENT DIRECTLY CAUSED OR WAS ATTRIBUTABLE TO THE USAGE OF DEVICE FOLEY CATHETER AND RESULTED IN THE FOLLOWING COMPLICATIONS: SEPSIS. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR SEPSIS. PER ADDITIONAL INFORMATION RECEIVED VIA MAIL ON 13DEC2024, STATED THAT THE RESPONDENT INDICATED THE PATIENT DID REQUIRED MEDICAL OR SURGICAL INTERVENTION AND INDICATED SURGERY.
Patient problems: Sepsis
MAUDE report 20797824 ↗MalfunctionMay 23, 2018Leak/Splash
IT WAS REPORTED THAT THE CATHETER LEAKED AROUND THE MEATUS AFTER ABOUT 2 HOURS OF PLACEMENT. THE CATHETER WAS REPORTEDLY REPLACED.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 7539293 ↗
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® I.C. Temperature Sensing Foley Catheter 129414MC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES436 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
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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