Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubri-Sil® I.C. All-Silicone Coated 5 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
Quick summary
This Bard Bardex Lubri-Sil Foley catheter has 747 reports, with no deaths and 9 injuries. Many reports describe holes or tears in the catheter, a balloon that does not deflate, and leaks, and some describe the catheter coming out on its own. Reports fell to 56 in the past 12 months from 535 in the 12 months before. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 778
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 778 adverse event reports that list this exact device (DI 00801741025211), received between Oct 25, 2018 and Sep 30, 2026 — classified as 10 injuries, 768 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (309 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 Puncture/Hole309
- Deflation Problem144
- Material Rupture99
- Fluid/Blood Leak91
- Material Split, Cut or Torn59
- Component Misassembled49
- Inflation Problem41
- Difficult to Remove28
Patient problems
- No Clinical Signs, Symptoms or Conditions751
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available7
- Pain6
- No Known Impact Or Consequence To Patient5
- Discomfort4
- No Consequences Or Impact To Patient4
- Hematuria2
- Urinary Incontinence2
Recent adverse event reports
The 25 most recent of 778 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
It was reported that during use the balloon is torn from the foley catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950950 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917218 ↗MalfunctionSep 24, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889823 ↗MalfunctionSep 24, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889818 ↗MalfunctionSep 23, 2026Material Puncture/Hole
It was reported that spontaneous dislodgement of the Foley Catheter after placement. Since urine flow could not be confirmed after insertion, the Foley catheter was checked and found to have fallen out. Upon refilling, a leak from the balloon was confirmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873290 ↗MalfunctionSep 21, 2026Difficult to Remove
Patient problems: Pain
MAUDE report 50848296 ↗InjurySep 21, 2026Difficult to Remove
Patient problems: Pain
MAUDE report 50848295 ↗MalfunctionSep 18, 2026Material Puncture/Hole
It was reported that during use the Balloon section foley catheter was placed on (b)(6) and spontaneously removed on (b)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819867 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809609 ↗MalfunctionSep 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809588 ↗MalfunctionSep 17, 2026Material Puncture/Hole
It was reported that a catheter was inserted in the OPE room for urinary catheterization, and while the patient was being monitored on the 17th floor North Ward, the catheter reportedly dislodged spontaneously. When sterile water is infused, it is ejected through the catheter lumen.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50802935 ↗MalfunctionSep 15, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50782011 ↗MalfunctionSep 15, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50781539 ↗MalfunctionSep 14, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765265 ↗MalfunctionSep 3, 2026Fluid/Blood Leak
It was reported that during surgery, shortly after starting Urinary leakage was seen. No medical intervention was reported.Per follow up information received via IBC on 15JUL2025, stated that the actual event for which urinary incontinence happened was unknown and no patient or user was harmed.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50578065 ↗MalfunctionAug 27, 2026Material Puncture/Hole
It was reported that spontaneous dislodgement was confirmed after placement of the foley catheter. Upon checking balloon expansion with tap water, a pinhole was discovered. Spontaneous dislodgement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50482350 ↗MalfunctionAug 26, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452741 ↗MalfunctionAug 21, 2026Material Puncture/Hole; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50382774 ↗MalfunctionAug 19, 2026Material Rupture; Device Dislodged or Dislocated
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50329992 ↗MalfunctionAug 14, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50254988 ↗MalfunctionAug 11, 2026Material Puncture/Hole
It was reported that during use sterile water leak in the foley catheter.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50206246 ↗MalfunctionJul 29, 2026Fluid/Blood Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50071616 ↗MalfunctionJul 29, 2026Fluid/Blood Leak; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50070603 ↗MalfunctionJul 28, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50059475 ↗MalfunctionJul 27, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50022352 ↗
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® 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
- SureStep™ Foley Tray System Bardex® I.C. Complete Care Foley Catheter A319416AMC. R. Bard, Inc. · CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 recalls18 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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