Bardex Lubri-Sil I.C. All-Silicone Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 26 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,518
- Deaths reported
- 1
- Injuries reported
- 60
- Recalls
- 0
We found 26 models of Bardex Lubri-Sil I.C. All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,518 adverse event reports in the FDA's MAUDE database, received between Aug 16, 2017 and Sep 30, 2026 — classified as 1 death, 60 injuries, 1,457 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (531 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Bardex Lubri-Sil I.C. All-Silicone Foley Catheter problems
Device problems
- Material Puncture/Hole531
- Material Rupture224
- Deflation Problem203
- Fluid/Blood Leak166
- Component Misassembled109
- Inflation Problem90
- Material Split, Cut or Torn90
- Difficult to Remove72
Patient problems
- No Clinical Signs, Symptoms or Conditions1,300
- No Known Impact Or Consequence To Patient111
- No Consequences Or Impact To Patient103
- Pain29
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available27
- Urinary Tract Infection15
- No Patient Involvement12
- Foreign Body In Patient8
Bardex Lubri-Sil I.C. All-Silicone Foley Catheter models
26 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI14CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES778 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI16CATHETER, RETENTION TYPE, BALLOON1 death383 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI12CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES165 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI18CATHETER, RETENTION TYPE, BALLOON38 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI16CATHETER, RETENTION TYPE, BALLOON32 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI20CATHETER, RETENTION TYPE, BALLOON18 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI12CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES13 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI14CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES12 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI24CATHETER, RETENTION TYPE, BALLOON10 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI18CATHETER, RETENTION TYPE, BALLOON9 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70516SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES9 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI20CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES6 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73018SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES6 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI24CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 0170SI20CATHETER, RETENTION TYPE, BALLOON4 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70522SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73016SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES4 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1758SI22CATHETER, RETENTION TYPE, BALLOON3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI16CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI22CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73020SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73022SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 73024SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES3 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 1768SI18CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70520SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES2 reports
- Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter 70518SICATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES1 report
Recent Bardex Lubri-Sil I.C. All-Silicone Foley Catheter adverse event reports
The 15 most recent reports across all models, 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 29, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940867 ↗MalfunctionSep 29, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935977 ↗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 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubricath Foley Catheter38 models · 1,670 reports · 1 recall
- Magic3 Coude Intermittent Catheter with Sure-Grip Sleeve5 models · 1,466 reports
- Magic3 Intermittent Catheter with Sure-Grip Sleeve14 models · 1,310 reports
- Bardia Foley Catheter Silicone Coated19 models · 1,283 reports
- PureWick Female External Catheter5 models · 1,184 reports
- Bardex All-Silicone Foley Catheter12 models · 1,170 reports
- PureWick Urine Collection System3 models · 1,096 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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