BardiaRecalls & reported problems across all models
C. R. Bard, Inc. · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 47
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls
- 0
We found 11 models of Bardia by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 47 adverse event reports in the FDA's MAUDE database, received between Dec 4, 2018 and Sep 30, 2026 — classified as 6 injuries, 41 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (17 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 Bardia problems
Device problems
- Material Rupture17
- Difficult to Remove5
- Disconnection5
- Deflation Problem4
- Material Puncture/Hole4
- Material Split, Cut or Torn3
- Component Misassembled2
- Fluid/Blood Leak2
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Exposure to Body Fluids5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient2
- Foreign Body In Patient1
- Insufficient Information1
Bardia models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardia 123516CECATHETER, COUDE17 reports
- Bardia 123514CECATHETER, COUDE14 reports
- Bardia 123614CECATHETER, UROLOGICAL3 reports
- Bardia 123512CECATHETER, COUDE2 reports
- Bardia 123518CECATHETER, COUDE2 reports
- Bardia 123612CECATHETER, UROLOGICAL2 reports
- Bardia 123618CECATHETER, UROLOGICAL2 reports
- Bardia 123622CECATHETER, UROLOGICAL2 reports
- Bardia 123520CECATHETER, COUDE1 report
- Bardia 123522CECATHETER, COUDE1 report
- Bardia 123628CECATHETER, UROLOGICAL1 report
Recent Bardia 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
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50952617 ↗MalfunctionSep 30, 2026Material Rupture
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50952616 ↗MalfunctionAug 21, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50377863 ↗MalfunctionJun 3, 2026Fungus in Device Environment; Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE TRIAL SAMPLE WAS TESTED USING TGC BROTH CULTURE FOR 14 DAYS, AND FUNGAL GROWTH WAS DETECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25382751 ↗MalfunctionJun 1, 2026Fluid/Blood Leak; Material Split, Cut or Torn
It was reported that thirty minutes after foley catheter insertion, leakage was observed. Upon inspection, it was found that the catheter bifurcation was damaged.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25352859 ↗MalfunctionApr 25, 2026Material Rupture
IT WAS REPORTED THAT THE PATIENT CALLED SAYING HER FOLEY CATHETER CAME OUT. WHEN CUSTOMER WENT TO CHECK, THEY SAW THE FOLEY ON THE FLOOR AT THE BEDSIDE. AFTER INSPECTING THE CATHETER CLOSELY, IT LOOKS LIKE THE BALLOON HOLDING IT IN PLACE HAD BURST RESULTING IN THE CATHETER SLIPPING OUT. NEW FOLEY WAS INSERTED WHEN PATIENT WAS BACK IN BED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24993084 ↗InjuryApr 7, 2026Deflation Problem
IT WAS REPORTED THAT THE PATIENT SAID THE BALLOON WOULD NOT DEFLATE AND SHE WAS RUSHED TO THE EMERGENCY ROOM TO HAVE THE CATHETER REMOVED. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24800645 ↗MalfunctionMar 30, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER BALLON HAD WATER LEAKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24714083 ↗InjuryMar 20, 2026Material Rupture
IT WAS REPORTED THAT THE PATIENT ARRIVED AT (B)(6) CLINIC HAVING HAD SUPRAPUBIC CATHETER REMOVED BY HOMECARE. PATIENT REQUIRED RE-INSERTION OF SAME. WHILE PATIENT WAS BEING SCOPED THE PHYSICIAN NOTED A PIECE OF THE BALLOON STILL IN THE BLADDER AND WAS ABLE TO SUCCESSFULLY REMOVE SAME. CATHETER WAS A 16 FRENCH BARD LATEX FOLEY THAT HAD BEEN INSERTED ON (B)(6) 2026. BALLOON HAD BEEN PROPERLY INFLATED WITH THE CORRECT AMOUNT OF FLUID.
Patient problems: Foreign Body In Patient
MAUDE report 24649575 ↗MalfunctionMar 18, 2026Material Rupture
IT WAS REPORTED THAT FOLEY CATHETER BALLOON GOT RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24630984 ↗MalfunctionMar 7, 2026Material Rupture
IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2026 DUE TO 'GROSS HEMATURIA FOR 5 DAYS.' THE MEDICAL ORDER WAS TO PERFORM PERCUTANEOUS BLADDER ARTERY EMBOLIZATION UNDER LOCAL ANESTHESIA, TRANSCATHETER INTERNAL ILIAC ARTERY EMBOLIZATION AND ILIAC ARTERY ANGIOGRAPHY ON (B)(6) 2026, WITH FOLEY CATHETER RETENTION AND CONTINUOUS BLADDER IRRIGATION. WHILE THE NURSE WAS CHECKING THE PATIENT'S DRAINAGE DURING WARD ROUNDS, IT WAS FOUND THAT THE CATHETER HAD OBVIOUSLY SLID OUT. UPON ASKING, THE PATIENT REPORTED THAT AT 14:00, THEY FELT AN UNUSUAL SOUND INSIDE THEIR BODY. A DOCTOR WAS CALLED TO CHECK THE CATHETER AND FOUND THAT THE BALLOON HAD RUPTURED, BUT A CAREFUL EXAMINATION SHOWED THE RUPTURED PART WAS INTACT WITH NO DEFECTS. THE DOCTOR SUGGESTED CONTINUING CATHETER RETENTION, BUT THE PATIENT REFUSED. THE PATIENT'S URINATION AND OTHER CONDITIONS WERE SUBSEQUENTLY OBSERVED, AND NO CATHETERIZATION WAS PERFORMED FOR THE TIME BEING, ENCOURAGING THE PATIENT TO URINATE INDEPENDENTLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24540821 ↗MalfunctionFeb 27, 2026Material Rupture
IT WAS REPORTED THAT TEN DAYS AFTER THE PATIENT'S PROSTATECTOMY, AN INDWELLING FOLEY CATHETER WAS LEFT IN PLACE DURING SURGERY. ON THE AFTERNOON OF (B)(6) 2026, DURING THE DOCTOR'S ROUNDS, IT WAS FOUND THAT THE CATHETER HAD SLIPPED OUT ON ITS OWN. UPON INSPECTION, IT WAS DISCOVERED THAT THE CATHETER BALLOON WAS RUPTURED, CAUSING THE FLUID INSIDE THE BALLOON TO LEAK OUT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24470807 ↗MalfunctionJan 12, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING USE THE FOLEY CATHETER SLIPPED OUT WITH BALLOON DEFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24048946 ↗MalfunctionJan 12, 2026Inflation Problem
IT WAS REPORTED THAT, THE URINARY FOLEY CATHETER BALLOON COULD NOT BE INFLATED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24037336 ↗MalfunctionJan 7, 2026Material Rupture
IT WAS REPORTED THAT, FOLEY CATHETER BALLOON WAS RUPTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23999516 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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