Bardex Lubricath Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 38 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Bardex Lubricath Foley Catheter model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1,670
- Deaths reported
- 0
- Injuries reported
- 104
- Recalls
- 1
We found 38 models of Bardex Lubricath Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,670 adverse event reports in the FDA's MAUDE database, received between Apr 27, 2017 and Sep 29, 2026 — classified as 104 injuries, 1,566 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (307 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Bardex Lubricath Foley Catheter recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jun 25, 2026Class IIOpen, Classified
Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays.
Z-3114-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Bardex Lubricath Foley Catheter problems
Device problems
- Material Puncture/Hole307
- Material Rupture280
- Deflation Problem193
- Difficult to Remove142
- Inflation Problem129
- Fluid/Blood Leak123
- Partial Blockage84
- Inaccurate Flow Rate58
Patient problems
- No Clinical Signs, Symptoms or Conditions1,260
- No Consequences Or Impact To Patient203
- No Known Impact Or Consequence To Patient165
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available62
- Pain31
- Foreign Body In Patient29
- Discomfort20
- No Patient Involvement15
Bardex Lubricath Foley Catheter models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubricath® Foley Catheter 0165L14CATHETER, COUDE562 reports
- Bardex® Lubricath® Foley Catheter 0165L16CATHETER, COUDE539 reports
- Bardex® Lubricath® Foley Catheter 0165L18CATHETER, COUDE111 reports
- Bardex® Lubricath® Foley Catheter 0165L12CATHETER, COUDE59 reports
- Bardex® Lubricath® Foley Catheter 0165L20CATHETER, COUDE56 reports
- Bardex® Lubricath® Foley Catheter A304916CATHETER, COUDE1 recall5 reports
- Bardex® Lubricath® Foley Catheter 0165L24CATHETER, COUDE31 reports
- Bardex® Lubricath® Foley Catheter 0119L18CATHETER, COUDE30 reports
- Bardex® Lubricath® Foley Catheter 0167L18CATHETER, UROLOGICAL29 reports
- Bardex® Lubricath® Foley Catheter 0119L20CATHETER, COUDE26 reports
- Bardex® Lubricath® Foley Catheter 0167L20CATHETER, UROLOGICAL25 reports
- Bardex® Lubricath® Foley Catheter 0167L22CATHETER, UROLOGICAL24 reports
- Bardex® Lubricath® Foley Catheter 0165L22CATHETER, COUDE17 reports
- Bardex® Lubricath® Foley Catheter 0166L16CATHETER, UROLOGICAL16 reports
- Bardex® Lubricath® Foley Catheter 0166L20CATHETER, UROLOGICAL16 reports
- Bardex® Lubricath® Foley Catheter 0119L16CATHETER, COUDE15 reports
- Bardex® Lubricath® Foley Catheter 0166L18CATHETER, UROLOGICAL14 reports
- Bardex® Lubricath® Foley Catheter 0167L24CATHETER, UROLOGICAL11 reports
- Bardex® Lubricath® Foley Catheter 01237524CATHETER, COUDE10 reports
- Bardex® Lubricath® Foley Catheter 0167L16CATHETER, UROLOGICAL9 reports
- Bardex® Lubricath® Foley Catheter 0166L24CATHETER, UROLOGICAL8 reports
- Bardex® Lubricath® Foley Catheter 0165L26CATHETER, COUDE7 reports
- Bardex® Lubricath® Foley Catheter 0166L14CATHETER, UROLOGICAL6 reports
- Bardex® Lubricath® Foley Catheter 0166L22CATHETER, UROLOGICAL6 reports
- Bardex® Lubricath® Foley Catheter 0119L22CATHETER, COUDE5 reports
- Bardex® Lubricath® Foley Catheter 0166L28CATHETER, UROLOGICAL4 reports
- Bardex® Lubricath® Foley Catheter 01237522CATHETER, COUDE4 reports
- Bardex® Lubricath® Foley Catheter 0125RL22CATHETER, UROLOGICAL4 reports
- Bardex® Lubricath® Foley Catheter 0165L28CATHETER, COUDE3 reports
- Bardex® Lubricath® Foley Catheter 0166L30CATHETER, UROLOGICAL3 reports
- Bardex® Lubricath® Foley Catheter 0165GL16CATHETER, COUDE3 reports
- Bardex® Lubricath® Foley Catheter 0165L30CATHETER, COUDE2 reports
- Bardex® Lubricath® Foley Catheter 0166L12CATHETER, UROLOGICAL2 reports
- Bardex® Lubricath® Foley Catheter 0166L26CATHETER, UROLOGICAL2 reports
- Bardex® Lubricath® Foley Catheter 0167L26CATHETER, UROLOGICAL2 reports
- Bardex® Lubricath® Foley Catheter 0174L20CATHETER, COUDE2 reports
- Bardex® Lubricath® Foley Catheter 0125RL18CATHETER, UROLOGICAL1 report
- Bardex® Lubricath® Foley Catheter 0125RL20CATHETER, UROLOGICAL1 report
Recent Bardex Lubricath 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 29, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940868 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926205 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926183 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50924434 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923633 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Foreign Body In Patient
MAUDE report 50917214 ↗MalfunctionSep 28, 2026Material Rupture
Patient problems: Pain
MAUDE report 50916290 ↗MalfunctionSep 26, 2026Inaccurate Flow Rate
Patient problems: Pain; Urinary Retention
MAUDE report 50908456 ↗MalfunctionSep 25, 2026Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50903554 ↗MalfunctionSep 25, 2026Material Rupture
It was reported that nurse in Gloucester and had been out to a patient today who has had an issue with the catheter that was inserted on Tuesday (b)(6).They had been using a catheter valve effectively but when passing urine, they heard a noise like a deflating balloon and her catheter expelled. They kept this for me to review today and there is a noticeable spilt in the ballon for inflation. I have attached the photo for you to review.I just wondered if there has been any other issue with a batch of catheters. The one inserted was (b)(6) exp 15.9.28.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900321 ↗MalfunctionSep 24, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889821 ↗MalfunctionSep 23, 2026Component Missing
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50873309 ↗MalfunctionSep 21, 2026Fracture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848298 ↗MalfunctionSep 17, 2026Inflation Problem
It was reported that during use there was a hole in the foley catheter balloon, and it was expelled naturally.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809610 ↗MalfunctionSep 16, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790370 ↗
Other C. R. Bard, Inc. products
- Bardex I.C. Foley Catheter26 models · 3,607 reports
- Bardex Lubri-Sil I.C. All-Silicone Foley Catheter26 models · 1,518 reports
- 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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