Bard Tiemann Model Urological Catheter Coude TipRecalls & reported problems across all models
C. R. Bard, Inc. · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 193
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 0
We found 5 models of Bard Tiemann Model Urological Catheter Coude Tip by C. R. Bard, Inc. in the FDA's device registry (GUDID). Together they are named in 193 adverse event reports in the FDA's MAUDE database, received between May 23, 2017 and Aug 5, 2026 — classified as 14 injuries, 179 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (48 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 Tiemann Model Urological Catheter Coude Tip problems
Device problems
- Component Misassembled48
- Material Twisted/Bent31
- Incorrect Measurement25
- Difficult to Insert24
- Nonstandard Device11
- Misassembled10
- Bent8
- Material Deformation7
Patient problems
- No Clinical Signs, Symptoms or Conditions93
- No Known Impact Or Consequence To Patient51
- No Consequences Or Impact To Patient50
- Pain15
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available12
- Urinary Tract Infection8
- No Patient Involvement7
- Discomfort6
Bard Tiemann Model Urological Catheter Coude Tip models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Bard® Tiemann Model Urological Catheter Coude Tip 010114CATHETER, UROLOGICAL95 reports
- Bard® Tiemann Model Urological Catheter Coude Tip 010116CATHETER, UROLOGICAL66 reports
- Bard® Tiemann Model Urological Catheter Coude Tip 010118CATHETER, UROLOGICAL18 reports
- Bard® Tiemann Model Urological Catheter Coude Tip 010112CATHETER, UROLOGICAL13 reports
- Bard® Tiemann Model Urological Catheter Coude Tip 010120CATHETER, UROLOGICAL1 report
Recent Bard Tiemann Model Urological 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.
MalfunctionAug 5, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150042 ↗MalfunctionAug 5, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150040 ↗MalfunctionAug 5, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150039 ↗MalfunctionAug 5, 2026Incorrect Measurement
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50150038 ↗MalfunctionJul 18, 2026Material Protrusion/Extrusion
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25867180 ↗MalfunctionApr 22, 2026Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED AN EMAIL COMMUNICATION REGARDING A CUSTOMER COMPLAINT. THE COMPLAINT WAS RELATED TO BARD ITEM 010118 AND INVOLVED A SPECIFIC PATIENT CONCERN STATING THAT THE PRODUCT HAD CHANGED. THE PATIENT BELIEVED THAT A DEFECTIVE PRODUCT HAD BEEN RECEIVED. IT WAS REPORTED THAT SOME OF THE CATHETERS WERE LARGER, WHICH CAUSED PAIN AND BLEEDING TO OCCUR. THE CUSTOMER HAD BEEN SEEKING GUIDANCE, AND SINCE THIS DID NOT OCCUR OFTEN, THERE WAS A REQUEST TO UNDERSTAND BARD¿S PROCEDURES REGARDING CUSTOMER PRODUCT COMPLAINTS.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 24958391 ↗MalfunctionApr 10, 2026Incorrect Measurement
IT WAS REPORTED THAT THE PATIENT IS HAVING DIFFICULTY INSERTING THE CATHETER CAUSING PAIN AND BLEEDING AND HE NOTICED IT IS NOT THE SAME SIZE OF THE OTHER LOT#S. UNCLEAR IF MEDICAL INTERVENTION WAS PROVIDED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain
MAUDE report 24841560 ↗MalfunctionMar 30, 2026Incomplete or Missing Packaging; Material Twisted/Bent
IT WAS REPORTED THAT BARD 010114 MAY HAVE TRANSITIONED TO BD BRANDING. WITH BD BRANDED CATHETERS, THE ITEM CODE WAS STAMPED ON THE FOLEY CATHETER ITSELF BUT WAS DIFFICULT TO READ, WHEREAS THE CODE HAD BEEN EASIER TO READ WHEN THE PRODUCT WAS BARD BRANDED. ADDITIONALLY, THE DRAINAGE EYE APPEARED SMALLER. THE PRODUCT WAS ORDERED THROUGH BYRAM HEALTHCARE, AND IT WAS STATED THAT THEY ADD THE 10 BOXES OF 12 INTO ONE BOX SO THERE ARE 120 THAT SEEM TO GET TANGLED. THE TRANSITION FROM BARD TO BD AND CHANGES IN MANUFACTURING LOCATIONS WERE DISCUSSED. THE CUSTOMER WAS NOT UPSET BUT WISHED TO REPORT THE CONCERN IN CASE IT REPRESENTED A QUALITY ISSUE. CONTACTING BYRAM HEALTHCARE TO DETERMINE WHETHER THE PRODUCT COULD BE ORDERED DIFFERENTLY TO PREVENT TANGLING WAS DISCUSSED. THE MATTER WAS FORWARDED TO THE COMPLAINTS DEPARTMENT FOR APPROPRIATE HANDLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713488 ↗MalfunctionMar 30, 2026Incorrect Measurement
IT WAS REPORTED THAT BARD 010114 MAY HAVE TRANSITIONED TO BD BRANDING. WITH BD BRANDED CATHETERS, THE ITEM CODE WAS STAMPED ON THE FOLEY CATHETER ITSELF BUT WAS DIFFICULT TO READ, WHEREAS THE CODE HAD BEEN EASIER TO READ WHEN THE PRODUCT WAS BARD BRANDED. ADDITIONALLY, THE DRAINAGE EYE APPEARED SMALLER. THE PRODUCT WAS ORDERED THROUGH BYRAM HEALTHCARE, AND IT WAS STATED THAT THEY ADD THE 10 BOXES OF 12 INTO ONE BOX SO THERE ARE 120 THAT SEEM TO GET TANGLED. THE TRANSITION FROM BARD TO BD AND CHANGES IN MANUFACTURING LOCATIONS WERE DISCUSSED. THE CUSTOMER WAS NOT UPSET BUT WISHED TO REPORT THE CONCERN IN CASE IT REPRESENTED A QUALITY ISSUE. CONTACTING BYRAM HEALTHCARE TO DETERMINE WHETHER THE PRODUCT COULD BE ORDERED DIFFERENTLY TO PREVENT TANGLING WAS DISCUSSED. THE MATTER WAS FORWARDED TO THE COMPLAINTS DEPARTMENT FOR APPROPRIATE HANDLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24713448 ↗MalfunctionMar 17, 2026Incorrect Measurement
IT WAS REPORTED BY THE CUSTOMER THAT THE BARDAM COUDE CATHETER PRODUCT WAS LABELED AS EIGHTEEN FRENCH SIZE BUT APPEARED LARGER THAN THE CATHETERS PREVIOUSLY RECEIVED BY THE PATIENT. THE CUSTOMER STATED THAT THE PATIENT COMPARED ONE CATHETER FROM EACH BOX AND REPORTED THAT ALL APPEARED LARGER. THE CUSTOMER ALSO REPORTED THAT THE PRODUCT CAUSED CUTS AND BLEEDING FOR THE PATIENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Laceration(s)
MAUDE report 24621357 ↗MalfunctionFeb 18, 2026Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT THE INSIDE OF THE INTERMITTENT CATHETERS HAD APPEARED DIRTY, ALONG WITH THE COUDE TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24377161 ↗MalfunctionJan 23, 2026Incorrect Measurement
IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE DEFECTIVE. PATIENT STATED SOMETIMES THE CATHETERS ARE BIGGER THAN OTHERS AND CAN SOMETIMES BE TOO BIG TO BE ABLE TO USE. THE CURVE IN THE COUDE CATHETERS IS NOT ALWAYS THE SAME AND CORRECT. PATIENT SAID SOMETIMES THE COUDE TIP IS CURVED TOO MUCH OR NOT ENOUGH. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172775 ↗MalfunctionJan 23, 2026Component Misassembled
IT WAS REPORTED THAT THE PATIENT SAID THE CATHETERS ARE DEFECTIVE. PATIENT STATED SOMETIMES THE CATHETERS ARE BIGGER THAN OTHERS AND CAN SOMETIMES BE TOO BIG TO BE ABLE TO USE. THE CURVE IN THE COUDE CATHETERS IS NOT ALWAYS THE SAME AND CORRECT. PATIENT SAID SOMETIMES THE COUDE TIP IS CURVED TOO MUCH OR NOT ENOUGH. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24172771 ↗MalfunctionJan 23, 2026Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PATIENT SAID HE NOTICES THE PACKAGING IS NOT WATER / ALCOHOL PROOF AND WANTS A TECHNICIAN TO CALL HIM FROM BARD TO GO OVER SOLUTIONS AS HE IS CLAIMING THE CATHETERS ARE NOT STERILE. 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 24164317 ↗MalfunctionJan 22, 2026Device Contaminated During Manufacture or Shipping
IT WAS REPORTED THAT THE PATIENT SAID THE NEW PACKAGING IS EASILY CONTAMINATED AND HE HAS TO DECONTAMINATE EVERY TIME PRIOR TO USE. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO MEDICAL INTERVENTION OR PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24157205 ↗
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.
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