Bardex Lubricath Foley Catheter Coude TipRecalls & reported problems across all models
C. R. Bard, Inc. · 11 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 243
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls
- 0
We found 11 models of Bardex Lubricath Foley Catheter Coude Tip by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Apr 19, 2017 and Sep 28, 2026 — classified as 22 injuries, 221 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (21 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 Lubricath Foley Catheter Coude Tip problems
Device problems
- Fluid/Blood Leak21
- Difficult to Remove20
- Material Puncture/Hole20
- Inflation Problem19
- Component Misassembled18
- Burst Container or Vessel17
- Deflation Problem17
- Leak/Splash15
Patient problems
- No Clinical Signs, Symptoms or Conditions133
- No Known Impact Or Consequence To Patient71
- No Consequences Or Impact To Patient61
- No Patient Involvement22
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Foreign Body In Patient6
- Pain6
- Urinary Tract Infection4
Bardex Lubricath Foley Catheter Coude Tip models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L16CATHETER, COUDE89 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L14CATHETER, COUDE55 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L18CATHETER, COUDE27 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L12CATHETER, COUDE18 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L20CATHETER, COUDE16 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0100L18CATHETER, UROLOGICAL13 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0100L20CATHETER, UROLOGICAL10 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0168L22CATHETER, COUDE7 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0100L16CATHETER, UROLOGICAL6 reports
- Bardex® Lubricath® Foley Catheter Coude Tip 0100L22CATHETER, UROLOGICAL1 report
- Bardex® Lubricath® Foley Catheter Coude Tip 0100L24CATHETER, UROLOGICAL1 report
Recent Bardex Lubricath Foley Catheter Coude Tip adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Difficult to Remove
Patient problems: Insufficient Information
MAUDE report 50917216 ↗MalfunctionJun 5, 2026Difficult to Remove
IT WAS REPORTED BY CUSTOMER THAT THE 5 CC COUDE TIP TWO WAY PRE LUBRICATED CATHETER AFTER INSERTION, RESISTANCE WAS MET INFLATING THE BALLOON, AND ONLY 2ML OF SALINE WAS INSTILLED. UNABLE TO WITHDRAW 2ML OF SALINE TO REMOVE FOLEY. SURGICAL RESIDENT WAS UNABLE TO ALSO REMOVE SALINE FROM BALLOON BUT WAS ABLE TO REMOVE FOLEY. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25409245 ↗MalfunctionApr 22, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PT SAID THAT THERE WERE LEAKS WHERE THE TUBING CONNECTED TO CATH. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24958727 ↗MalfunctionApr 1, 2026Difficult to Remove
IT WAS REPORTED THAT AFTER USE THE FOLEY CATHETER WATER WOULDN'T DRAIN DUE TO THE CHIMAN STYLE DESIGN, SO THE SHAFT WAS CUT AND REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24758371 ↗MalfunctionMar 17, 2026Material Puncture/Hole
IT WAS REPORTED THAT THE NURSE HAD INSERTED THE COUDE CATHETER INTO A PATIENT AND LATER ON THAT SHIFT, THE FOLEY BALLOON HAD DEFLATED ON ITS OWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24621777 ↗MalfunctionMar 6, 2026Inflation Problem
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER CAUSED DIFFICULTY IN INJECTING WATER. THE VALVE FOR INJECTING FIXED WATER WAS CRACKED, MAKING IT DIFFICULT TO INJECT WATER, SO IT WAS DISCONTINUED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24535979 ↗MalfunctionFeb 23, 2026Nonstandard Device
IT WAS REPORTED THAT PATIENT STATED THE VALVE IS NOT WORKING ON THE FOLEY CATHETER. IT'S UNCLEAR IF LOT NUMBER WAS REQUESTED. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24422033 ↗MalfunctionFeb 20, 2026Inflation Problem
THE PATIENT RECEIVED TWO DEFECTIVE FOLEY CATHETERS. THE BALLOON WOULDN'T INFLATE. PATIENT NOW HAS A URINARY TRACT INFECTION. HE HAS HAD THE SAME FOLEY IN FOR OVER A MONTH. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408245 ↗InjuryFeb 20, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT RECEIVED TWO DEFECTIVE FOLEY CATHS. THE BALLOON WOULDN'T INFLATE. PATIENT NOW HAS A URINARY TRACT INFECTION. HE HAS HAD THE SAME FOLEY IN FOR OVER A MONTH. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTION.
Patient problems: Urinary Tract Infection
MAUDE report 24408237 ↗MalfunctionFeb 20, 2026Difficult to Remove
PATIENT SAID THE FOLEY BALLOON DID NOT DEFLATE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24408236 ↗MalfunctionJan 26, 2026Material Rupture
IT WAS REPORTED THAT THERE WAS A RUPTURE IN THE FOLEY CATHETER DURING PLACEMENT AND IT WAS SPONTANEOUSLY EXPELLED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185610 ↗MalfunctionJan 2, 2026Difficult to Remove
IT WAS REPORTED THAT DURING USE IT BECAME A DIFFICULT REMOVAL CASE OF THE FOLEY CATHETER AS RESISTANCE WAS FELT DURING REMOVAL, AND ALTHOUGH WATER WAS WITHDRAWN BY RECONNECTING THE SYRINGE, THE BALLOON DID NOT FULLY DEFLATE. THE REMOVAL WAS CARRIED OUT WITH SOME RESISTANCE, BUT IT WAS SUCCESSFULLY TAKEN OUT FROM THE PATIENT'S BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23951063 ↗MalfunctionDec 31, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT DURING USE WATER LEAKED FROM THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23936850 ↗MalfunctionDec 10, 2025Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT NATURAL REMOVAL OCCURRED OF THE FOLEY CATHETER SEVERAL HOURS AFTER PLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23771989 ↗MalfunctionDec 4, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT THE BALLOON ON THE LATEX FOLEY CATHETER DOES NOT BLOW-UP OR INFLATE CORRECTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23717330 ↗
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
- 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
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.
How reports and recalls are matched · Editorial policy · Report an error on this page