Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI24Recalls & 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
- 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 00801741025310), received between Aug 18, 2017 and Jun 27, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Dent in Material” (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.
Most reported problems
Device problems
- Dent in Material2
- Burst Container or Vessel1
- Failure to Infuse1
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- No Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2022Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT THE 24FR SILICONE FOLEY CATHETER HAD RUPTURED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14835760 ↗MalfunctionFeb 8, 2021Failure to Infuse; Dent in Material; Failure to Infuse; Dent in Material
IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING EVENLY IN THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11292193 ↗MalfunctionFeb 4, 2021Dent in Material; Dent in Material
IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT INFLATING EQUALLY ON EACH SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11280648 ↗MalfunctionAug 18, 2017No Flow
IT WAS REPORTED THAT THE CATHETER WOULD NOT DRAIN, EVEN AFTER FLUSHING.
Patient problems: No Information
MAUDE report 6805327 ↗
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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