Bardia Urethral CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 7 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 110
- Deaths reported
- 0
- Injuries reported
- 28
- Recalls
- 0
We found 7 models of Bardia Urethral Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 110 adverse event reports in the FDA's MAUDE database, received between Jun 28, 2017 and May 19, 2022 — classified as 28 injuries, 82 malfunctions.
The most frequently reported specific device problem is “Biocompatibility” (16 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
Most reported Bardia Urethral Catheter problems
Device problems
- Biocompatibility16
- Misassembled16
- Difficult to Insert15
- Incorrect Measurement12
- Adverse Event Without Identified Device or Use Problem10
- Inadequacy of Device Shape and/or Size10
- Device Damaged Prior to Use9
- Patient-Device Incompatibility9
Patient problems
- No Known Impact Or Consequence To Patient41
- No Consequences Or Impact To Patient38
- Urinary Tract Infection24
- No Clinical Signs, Symptoms or Conditions16
- No Patient Involvement12
- Pain9
- Hemorrhage/Blood Loss/Bleeding7
- Discomfort6
Bardia Urethral Catheter models
7 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bardia® Urethral Catheter 802414CATHETER, UROLOGICAL63 reports
- Bardia® Urethral Catheter 802416CATHETER, UROLOGICAL31 reports
- Bardia® Urethral Catheter 802412CATHETER, UROLOGICAL9 reports
- Bardia® Urethral Catheter 802410CATHETER, UROLOGICAL4 reports
- Bardia® Urethral Catheter 802418CATHETER, UROLOGICAL1 report
- Bardia® Urethral Catheter 802420CATHETER, UROLOGICAL1 report
- Bardia® Urethral Catheter 802422CATHETER, UROLOGICAL1 report
Recent Bardia Urethral Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 19, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE BARDIA URETHRAL CATHETER WAS NOT WELL SEALED IN ITS PRIMARY PACKAGING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14434852 ↗MalfunctionNov 29, 2021Component Misassembled; Component Misassembled
IT WAS REPORTED THAT OCCASIONALLY THERE WAS ONE RED RUBBER INTERMITTENT CATHETER THAT HAD SMALLER DIAMETER, SOFTER AND MORE FLEXIBLE AND WERE HENCE NOT USABLE FOR THE CUSTOMER AS THE RIGIDITY NEEDED WAS NOT THAT OF THE USUAL SIZE. IN THE PAST FEW MONTHS, CUSTOMER NOTED THAT THE NUMBER OF THESE DIFFERENT CATHETERS WERE ON THE RISE. CUSTOMER STATED THAT 9 CATHETERS WERE FOUND IN A BOX OF 100. CUSTOMER ALSO STATED THAT THE DIFFERENCE WAS CLEAR BOTH TO VISUAL INSPECTION AND TO FEEL. PER FOLLOW UP ON (B)(6) 2021, CUSTOMER HAD OCCASIONAL THIN-WALLED, SMALLER DIAMETER ONE IN A BOX OF 100. THE CURRENT BOX OF 100 THAT THE CUSTOMER WAS ABOUT TO FINISH HAD 38 OF THE THINNER ONES IN IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12885551 ↗MalfunctionNov 8, 2021Component Misassembled; Component Misassembled
IT WAS REPORTED THAT PATIENT HAD DIFFICULTY TO INSERT THE CATHETER. FOLLOW UP VIA PHONE ON 24MAR2021, THE CUSTOMER NOTED THAT THE END OF THE CATHETER WAS VERY FLOPPY BECAUSE THE HOLES ARE OPPOSITE EACH OTHER SO, IT KEPT BENDING DURING INSERTION. WHICH MADE IT PAINFUL AND DIFFICULT TO INSERT THE FIRST 3 INCHES OF THE CATHETER. THE CUSTOMER WAS STILL ABLE TO INSERT THE CATHETER AND VOID THE BLADDER. THE CUSTOMER ADDED THAT THE MATERIAL ON THE CATHETER WAS NOT SMOOTH AND WAS A LITTLE ROUGH. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12769963 ↗MalfunctionJun 9, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE INTERMITTENT CATHETER HAD A PROTRUSION ABOUT 6 INCHES FROM THE EXIT WHILE USING IT. NO INJURY WAS REPORTED, JUST A CONCERN AS IT ALMOST REACHED THE PATIENT'S URETHRA. PER FOLLOW UP VIA PHONE (B)(6). 2021, CUSTOMER STATED THAT THE PROTRUSION WAS ONLY ABOUT A MILLIMETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11971582 ↗MalfunctionJun 4, 2021Incorrect Measurement; Material Protrusion/Extrusion; Incorrect Measurement; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE PATIENT STATED THE END OF THE BARDIA URETHRAL CATHETER WAS TOO BIG AND PATIENT WAS BLEEDING SOMETIMES. NO MEDICAL INTERVENTION IN EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11942435 ↗MalfunctionJun 4, 2021Incorrect Measurement; Material Protrusion/Extrusion; Incorrect Measurement; Material Protrusion/Extrusion
IT WAS REPORTED THAT THE PATIENT STATED THE END OF THE BARDIA URETHRAL CATHETER WAS TOO BIG AND PATIENT WAS BLEEDING SOMETIMES. NO MEDICAL INTERVENTION IN EVENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 11942434 ↗MalfunctionApr 26, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT SOME OF THE CATHETERS WERE OF DIFFERENT SIZE FROM THE OTHERS. PER INVESTIGATOR NOTIFICATION ON 02APR2021 DURING EVALUATION, IT WAS FOUND THAT THE CATHETER WAS FOUND TO BE HAVING INCORRECT FRENCH SIZE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11724423 ↗MalfunctionApr 21, 2021Material Protrusion/Extrusion; Sharp Edges; Material Protrusion/Extrusion; Sharp Edges
IT WAS REPORTED THAT THE PATIENT HAD DIFFICULTY IN INSERTING THE CATHETER. PER FOLLOW UP VIA PHONE ON 24MAR2021 THE CUSTOMER NOTED THAT THE END OF THE CATHETER WAS VERY FLOPPY BECAUSE THE HOLES WERE OPPOSITE EACH OTHER SO IT KEPT BENDING DURING THE INSERTION WHICH MADE IT PAINFUL AND DIFFICULT TO INSERT THE FIRST 3 INCHES OF THE CATHETER. THE CUSTOMER WAS STILL ABLE TO INSERT THE CATHETER AND VOID THE BLADDER. THE CUSTOMER STATED THAT THE MATERIAL ON THE CATHETER WAS NOT SMOOTH AND WAS A LITTLE ROUGH. NO MEDICAL INTERVENTION WAS REQUIRED.
Patient problems: Pain
MAUDE report 11701535 ↗InjuryApr 19, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT HAD URINARY TRACT INFECTION AND ALTHOUGH THERE WAS NO ALLEGATION AGAINST THE PRODUCT. HISTORICALLY, THE PATIENT WAS PROVIDED WITH THE TOUCHLESS PLUS CATHETER. PER SAMPLE RECEIVED ON 23MAR2020, IT WAS NOTED THAT A BARDIA URETHRAL RED RUBBER CATHETER WAS RECEIVED FOR EVALUATION. IT WAS UNKNOWN WHETHER MEDICAL INTERVENTION WAS PROVIDED.
Patient problems: Urinary Tract Infection
MAUDE report 11689433 ↗InjuryMar 18, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT EXPERIENCED TWO INFECTIONS AND BELIEVED IT IS FROM THE BARDIA URETHRAL CATHETER PRODUCT. THE PATIENT ALSO SAID WHEN THE ORDER WAS ARRIVED IT APPEARED TO HAVE BEEN RAINED ON AND IT SEEMED THE BOX WAS RETAPED.
Patient problems: Unspecified Infection
MAUDE report 11518567 ↗MalfunctionMar 16, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE CATHETERS WERE TOO BIG TO FIT INTO THE PATIENT STOMA. THE PATIENT STATED THAT THE CATHETER SEEMED TO BE MADE OF SOMETHING DIFFERENT. THE PATIENT ALSO REPORTED THAT LITTLE KNOTS WERE FOUND ON THE CATHETER AND THERE WAS NO HARM OR HOSPITALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11497165 ↗MalfunctionMar 15, 2021Incorrect Measurement; Inadequacy of Device Shape and/or Size; Incorrect Measurement; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE CATHETERS WERE BIG TO FIT IN THE USER STOMA. IT WAS STATED THAT THERE WERE LITTLE KNOTS ON THE CATHETERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11485975 ↗InjuryFeb 16, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS AND WAS THOUGHT THAT IT IS BECAUSE OF CATHETERS, HOWEVER, IT WAS NOT SURE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.
Patient problems: Urinary Tract Infection
MAUDE report 11333265 ↗InjuryFeb 16, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS AND WAS THOUGHT THAT IT IS BECAUSE OF CATHETERS, HOWEVER, IT WAS NOT SURE. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.
Patient problems: Urinary Tract Infection
MAUDE report 11333250 ↗InjuryFeb 16, 2021Biocompatibility; Biocompatibility
IT WAS REPORTED THAT THE PATIENT HAD GOT 3 URINARY TRACT INFECTIONS. THEY THOUGHT THAT IT WAS THE CATHETERS BUT NOT SURE AND STATED THAT THEY ONLY GOT ONE A YEAR USUALLY. IT WAS UNKNOWN WHAT MEDICAL INTERVENTION WAS PROVIDED FOR URINARY TRACT INFECTIONS.
Patient problems: Urinary Tract Infection
MAUDE report 11333016 ↗
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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