Bardex All-Silicone Foley CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 12 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,170
- Deaths reported
- 0
- Injuries reported
- 113
- Recalls
- 0
We found 12 models of Bardex All-Silicone Foley Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 1,170 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2017 and Sep 30, 2026 — classified as 113 injuries, 1,057 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (187 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 All-Silicone Foley Catheter problems
Device problems
- Material Puncture/Hole187
- Difficult to Remove156
- Deflation Problem144
- Material Invagination129
- Fluid/Blood Leak92
- Material Rupture91
- Burst Container or Vessel72
- Decrease in Pressure70
Patient problems
- No Clinical Signs, Symptoms or Conditions629
- No Known Impact Or Consequence To Patient238
- No Consequences Or Impact To Patient197
- Pain88
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available81
- No Patient Involvement39
- Discomfort35
- Urinary Tract Infection35
Bardex All-Silicone Foley Catheter models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardex® All-Silicone Foley Catheter 165816CATHETER, RETENTION TYPE, BALLOON512 reports
- Bardex® All-Silicone Foley Catheter 165814CATHETER, URETHRAL275 reports
- Bardex® All-Silicone Foley Catheter 165812CATHETER, RETENTION TYPE, BALLOON151 reports
- Bardex® All-Silicone Foley Catheter 165818CATHETER, RETENTION TYPE, BALLOON85 reports
- Bardex® All-Silicone Foley Catheter 165820CATHETER, RETENTION TYPE, BALLOON52 reports
- Bardex® All-Silicone Foley Catheter 166816CATHETER, URETHRAL26 reports
- Bardex® All-Silicone Foley Catheter 165824CATHETER, RETENTION TYPE, BALLOON19 reports
- Bardex® All-Silicone Foley Catheter 166818CATHETER, URETHRAL17 reports
- Bardex® All-Silicone Foley Catheter 165822CATHETER, RETENTION TYPE, BALLOON12 reports
- Bardex® All-Silicone Foley Catheter 166822CATHETER, URETHRAL9 reports
- Bardex® All-Silicone Foley Catheter 166820CATHETER, URETHRAL6 reports
- Bardex® All-Silicone Foley Catheter 166824CATHETER, URETHRAL6 reports
Recent Bardex 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, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954483 ↗MalfunctionSep 1, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547363 ↗InjuryAug 25, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441867 ↗MalfunctionAug 4, 2026Difficult to Remove
Patient problems: Pain
MAUDE report 50130660 ↗MalfunctionJul 30, 2026Sharp Edges
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50092631 ↗MalfunctionJul 27, 2026Inflation Problem; Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50039143 ↗MalfunctionJul 27, 2026Material Puncture/Hole; Material Rupture
It was reported that at around 14:00 hrs, prior to patient being transferred from bed to wheelchair, patient's incontinent brief was noted to be soiled. Both PCA and primary nurse intended to provide perineal care prior to transfer. Upon opening brief, foley catheter came out. Foley catheter tip noted to not be inflated. Balloon area was flat. Patient informed primary nurse that the catheter was inserted the day before. Primary nurse assessed foley catheter but using 10 ml syringe and trying to inflate it. No balloon inflation noted, instead, leakage noted. At the time primary nurse inserted a brand-new catheter of the same product. Balloon was inflated of 10 ml. Resistance noted. Urine output noted. One day later, at around 09:30 hrs, foley catheter was initially insitu until during med pass as patient was complaining of discomfort from foley catheter. Patient felt as if foley was not in place. Primary nurse assessed and tugged on catheter with no resistance noted. Primary nurse removed.
Patient problems: Discomfort
MAUDE report 50022111 ↗MalfunctionJul 21, 2026Inflation Problem; Material Puncture/Hole; Material Rupture
IT WAS REPORTED THAT AT AROUND 14:00 HRS, PRIOR TO PATIENT BEING TRANSFERRED FROM BED TO WHEELCHAIR, PATIENT'S INCONTINENT BRIEF WAS NOTED TO BE SOILED. BOTH PCA AND PRIMARY NURSE INTENDED TO PROVIDE PERINEAL CARE PRIOR TO TRANSFER. UPON OPENING BRIEF, FOLEY CATHETER CAME OUT. FOLEY CATHETER TIP NOTED TO NOT BE INFLATED. BALLOON AREA WAS FLAT. PATIENT INFORMED PRIMARY NURSE THAT THE CATHETER WAS INSERTED THE DAY BEFORE. PRIMARY NURSE ASSESSED FOLEY CATHETER BUT USING 10 ML SYRINGE AND TRYING TO INFLATE IT. NO BALLOON INFLATION NOTED, INSTEAD, LEAKAGE NOTED. AT THE TIME PRIMARY NURSE INSERTED A BRAND-NEW CATHETER OF THE SAME PRODUCT. BALLOON WAS INFLATED OF 10 ML. RESISTANCE NOTED. URINE OUTPUT NOTED. ONE DAY LATER, AT AROUND 09:30 HRS, FOLEY CATHETER WAS INITIALLY INSITU UNTIL DURING MED PASS AS PATIENT WAS COMPLAINING OF DISCOMFORT FROM FOLEY CATHETER. PATIENT FELT AS IF FOLEY WAS NOT IN PLACE. PRIMARY NURSE ASSESSED AND TUGGED ON CATHETER WITH NO RESISTANCE NOTED. PRIMARY NURSE REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25884686 ↗MalfunctionJul 19, 2026Sharp Edges
Patient problems: Hematuria; Insufficient Information
MAUDE report 25867755 ↗MalfunctionJul 19, 2026Sharp Edges
IT WAS REPORTED THAT DURING USE THERE WERE COMPLAINTS FROM VARIOUS PARTS OF THE OR ABOUT THIS BARDEX ALL-SILICONE 2-WAY URINARY FOLEY CATHETER. THEY WERE ALSO SEEING AN INCREASED NUMBER OF PATIENTS WITH HEMATURIA, AND IT WAS ASKED IF THERE HAD ANY RECENT CHANGES TO THE CATHETER. NOTHING WAS FOUND ABOUT THAT IN THE FILE ONLY DOCUMENTED AT THE END OF 2024 DID NOT SAW ANY SUPPLIED ALTERNATIVES. THIS CONCERNS LOT MYKZ2589 AND STILL HAD STOCK. THEY ARE WILLING TO CONTACT BD REGARDING THE ISSUE OR PERHAPS IF A SALES REPRESENTATIVE OR PRODUCT SPECIALIST COULD ASSIST WITH THIS ISSUE.PER FOLLOW UP INFORMATION RECEIVED VIA RCC ON 10JUL2026, STATED THAT RECEIVED SO MANY COMPLAINTS ABOUT HEMATURIA FOLLOWING INSERTION THAT THIS IS NOT AN ISOLATED CASE. THE COLLEAGUES ARE PARTICULARLY SURPRISED BY THE SHAPE OF THE CATHETER, THE MULTIPLE RIDGES AND ARE WONDERING IF THEY¿RE DOING SOMETHING WRONG. PERHAPS IT WOULD BE BETTER IF YOU GAVE ME A QUICK CALL OR POPPED IN SOMETIME?PER FOLLOW UP INFORMATION RECEIVED ON 07/16/26, STATED THAT VISITED THE CLIENT TODAY AND SPOKE WITH VARIOUS DEPARTMENTS IN THE OR: SURGERY, CARDIOLOGY, AND UROLOGY. THEY ALL HAVE THE SAME PROBLEM: A DAMAGED URETHRA AFTER INSERTIN
Patient problems: Hematuria; Insufficient Information
MAUDE report 25867748 ↗MalfunctionJul 19, 2026Sharp Edges
Patient problems: Hematuria; Insufficient Information
MAUDE report 25867747 ↗MalfunctionJul 12, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING PLACEMENT IN THE SURGERY CENTER THE FOLEY CATHETER HAD A CRACK, CAUSING URINE LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791387 ↗MalfunctionJul 12, 2026Use of Device Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791371 ↗MalfunctionJul 12, 2026Material Invagination
IT WAS REPORTED THAT THE BALLOON HAD COMPLETELY DEFLATED AND A FOLD AT THE BALLOON LEVEL WAS VISIBLE AFTER REMOVAL ,2 OTHER CATHETERS WERE TESTED, AND THE BALLOON FOLDED EACH TIME, THIS ISSUE HAD BEEN RAISED IN 2025 BY ANOTHER SECTOR FOR THIS SAME PRODUCT. THE COMPLAINT WAS CANCELED AND NOT FORWARDED TO YOU BECAUSE THE STAFF HAD INFLATED THE BALLOON WITH 7ML INSTEAD OF THE INDICATED 5ML.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791276 ↗MalfunctionJul 12, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25791139 ↗
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
- 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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