Bard Urethral CatheterRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 96
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 5 models of Bard Urethral Catheter by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 96 adverse event reports in the FDA's MAUDE database, received between Jun 6, 2017 and Apr 9, 2026 — classified as 4 injuries, 92 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (23 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 Bard Urethral Catheter problems
Device problems
- Component Misassembled23
- Misassembled15
- Incorrect Measurement10
- Difficult to Insert8
- Material Twisted/Bent8
- Device Damaged Prior to Use6
- Failure to Align6
- Device Contamination with Chemical or Other Material4
Patient problems
- No Clinical Signs, Symptoms or Conditions45
- No Known Impact Or Consequence To Patient22
- No Consequences Or Impact To Patient17
- Pain8
- Patient Problem/Medical Problem8
- No Patient Involvement7
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available5
- Hemorrhage/Blood Loss/Bleeding5
Bard Urethral Catheter models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Urethral Catheter 120614CATHETER, UROLOGICAL55 reports
- Bard® Urethral Catheter 120616CATHETER, UROLOGICAL29 reports
- Bard® Urethral Catheter 120618CATHETER, UROLOGICAL7 reports
- Bard® Urethral Catheter 120612CATHETER, UROLOGICAL4 reports
- Bard® Urethral Catheter 120620CATHETER, UROLOGICAL1 report
Recent Bard Urethral Catheter adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 9, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE END-USER INSERTED INTERMITTENT LATEX CATHETER INTO URETHRA TO BLADDER AND PROCEEDED TO EMPTY BLADDER INTO THE CONTAINER. DURING THE PROCESS, THE PATIENT NOTICED THAT THEIR THIGH WAS GETTING WET. UPON EXAMINATION A SMALL HOLE WAS NOTED NEXT TO THE KNOB (BUMP) ON THE HUB. WHEN THE BLADDER WAS EMPTY, THE CATHETER TIP SYRINGE WAS PLACED INTO HUB AND THUMB WAS USED TO COVER THE HOLD AND BCG INSTALLED. THE PATIENT DENIED GETTING WET AFTER THE FIRST INCIDENT. NO SAMPLE WAS KEPT; HOWEVER, PICTURES OF INCIDENT ARE AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24829669 ↗MalfunctionJan 26, 2026Incorrect Measurement
IT WAS REPORTED THAT THE TIP OF THE CATHETER IS SHORTER AND THE CATHETER ITSELF IS THINNER THAN NORMAL. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24185749 ↗MalfunctionJul 10, 2025Improper Chemical Reaction; Improper Chemical Reaction
IT WAS REPORTED THAT RUBBER OF THE INTERMITTENT CATHETER WAS A DIFFERENT COLOR AND THE PATIENT WAS HAVING TO USE TWO PACKS OF LUBRICANT PER CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22470663 ↗MalfunctionJul 9, 2025Disconnection; Disconnection
IT WAS REPORTED THAT AFTER BLADDER INSTILLATION THERAPY, WRITER DEFLATED THE BALLOON AND REMOVED 10 MLS OF STERILE WATER. THE CAP SUDDENLY DETACHED FROM THE RED RUBBER CATHETER AND UNABLE TO UNLATCHED THE SYRINGE. UNLATCHED THE SYRINGE AFTER FEW ATTEMPTS OF REMOVAL. INFORMED THE PATIENT WHAT HAPPENED, NO HARM WAS DONE. TREATMENT WAS FINISHED AND PATIENT LEFT UNIT WITH NO VOICED CONCERNS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22458100 ↗MalfunctionApr 2, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT CUSTOMER RECEIVED 2 ORDERS OF THEIR MONTHLY SUPPLY. BOTH WERE MARKED WITH THE CORRECT SIZE, BUT 1 BOX WAS BIGGER AND CUSTOMER STATED IT WAS NOT A 14F. IT¿S TO BIG CAUSING BLEEDING EVERY TIME WITH INSERTION AND THEY COULD NOT USE THEM. IT WAS NOTED THAT THE GIVEN LOT # WAS NGJW3614. PER CUSTOMER FOLLOW UP VIA PHONE ON 05APR2025, IT WAS REPORTED THAT CUSTOMER WANTED THE DEFECTIVE CATHETERS TO BE REPLACED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21751870 ↗MalfunctionMar 21, 2025Component Misassembled; Wrong Label; Component Misassembled; Wrong Label
IT WAS REPORTED THAT MISMARKED SIZING. PACKAGING SATED ONE SIZE BUT WHEN OPENED, THE CATHETERS WERE A DIFFERENT SIZE. SUPPOSED TO BE COUDE TIP AND SOME WERE NOT. NOT THE ENTIRE BOX, MISMATCHED IN THE BOX. CUSTOMER REQUESTED NEED WRONG SIZED AND SHAPED CATHETERS REPLACED. PER FOLLOW UP VIA EMAIL ON 04MAR2025, IT WAS REPORTED THAT CUSTOMER RECEIVED ABOUT 3 OR 4 MIS-SIZED CATHETERS; EACH WAS ONE SIZE LARGER (#18 INSTEAD OF #16) BUT WERE IDENTIFIED IN THE PACKAGING AS THE SMALLER SIZE. CUSTOMER HAVE NOT RECEIVED ANY SUCH MISMARKED CATHETERS SINCE. THE CATHETERS THAT HAD DEFECTIVE COUDE TIPS WERE THE CORRECT SIZE BUT MISSHAPEN TO THE EXTENT THAT THE TIPS HAD A VERY MINIMAL COUDE CURVE THAT WAS CONSIDERABLY SHALLOWER THAN NORMAL, AND THEREFORE UNUSABLE. CUSTOMER HAVE RETAINED A COUPLE OF SUCH CATHETERS. THEY WOULD ADD THAT THEY HAD ALSO RECEIVED SEVERAL CATHETERS WHOSE LENGTH, INSTEAD OF BEING STRAIGHT, WERE S-SHAPED AND/OR TWISTED. HOWEVER, NONE OF THESE DEFECTS HAVE APPEARED IN THEIR LATEST SHIPMENT. IN NO CASES HAVE I BEEN HARMED OR INJURED BY CATHETERS, ONLY INCONVENIENCED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21662948 ↗MalfunctionFeb 25, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT PRODUCT WAS DEFECTIVE. THEY EXCHANGED 20 INTERMITTENT CATHETERS BECAUSE THERE WAS A PROBLEM WITH THE TAPERING ON THEM. SOME WERE TOO SMALL AND SOME TOO BIG. IT WAS UNCOMFORTABLE. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Discomfort
MAUDE report 21460991 ↗MalfunctionFeb 25, 2025Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE INTERMITTENT CATHETER DID NOT HAD EYELETS. THAT WAS UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21458773 ↗MalfunctionFeb 25, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT INTERMITTENT CATHETERS WERE INCONSISTENT IN SIZE, AND SOME WERE REALLY BIG AT THE TIP AND SOME VERY SMALL. REPRESENTATIVE ADVISED CUSTOMER WOULD SEND UNUSED TO LIBERATOR REPRESENTATIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21457909 ↗MalfunctionFeb 6, 2025Incorrect Measurement; Material Too Rigid or Stiff; Incorrect Measurement; Material Too Rigid or Stiff
IT WAS REPORTED THAT LOT OF NEW INTERMITTENT CATHETERS CUSTOMER RECEIVED WAS UNSATISFACTORY. THEY WERE TOO STIFF, THE WALL DIAMETER APPEARED DIFFERENT AND WAS HAVING DIFFICULTY GETTING THE CATHETER INSERTED. THEY HAD SOME BLEEDING WHEN CATHETERIZING. THEY STATED THE CATHETER APPEARED TO BE MADE OUT OF A DIFFERENT MATERIAL, BUT THEY WERE BOTH MATERIAL#120614. OLD LOT THEY LIKED NGHZ2033, NEW LOT THEY DID NOT LIKE NGJT0067. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 21321528 ↗MalfunctionJan 16, 2025Material Protrusion/Extrusion; Material Protrusion/Extrusion
IT WAS REPORTED THAT CUSTOMER RECEIVED BARD INTERMITTENT CATHETERS, AND THEY WERE ORANGE, AND THEY WERE ROUGH EVEN WITH THE STERILE LUBRICATION JELLY. THEY REMEMBER A WHILE AGO THAT THEY WERE RED AND SOMEWHAT SMOOTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21168245 ↗MalfunctionJan 2, 2025Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE TOUCHLESS PLUS RED RUBBER INTERMITTENT CATHETER RUBBER WAS NOW A DIFFERENT COLOR AND TEXTURE SIZE. THE TIPS WERE FLIMSY, SO THEY COLLAPSED AND GOT CLOGGED AWAY EASIER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056224 ↗MalfunctionJun 6, 2024Difficult to Insert; Difficult to Insert
IT WAS REPORTED THAT THE CUSTOMER USED OF ONE HAND AND COULD GET THETIEMANN CATHETER 2/4 OF THE WAY IN BUT THEN THE TIEMANN CATHETER BENDS.IT WAS STATED THAT THE CAREGIVER COULD GET IT IN WITH NO ISSUE BUT THEY COULD NOT.IT WAS SENT SAMPLES BUT THEY WERE NOT WORKING WELL EITHER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19475696 ↗MalfunctionMar 20, 2024Decrease in Pressure; Material Puncture/Hole; Decrease in Pressure; Material Puncture/Hole
IT WAS REPORTED THAT THE INTERMITTENT CATHETER DEFLATED ON ITS OWN AND FELL OUT OF THE PATIENT. THE BALLOON WAS INFLATED TO 10CC DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18939628 ↗MalfunctionFeb 27, 2024Component Missing; Component Missing
IT WAS REPORTED THAT STILL MISSING 6 OUT OF THE INTERMITTENT CATHETER FROM THE REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18787633 ↗
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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