Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L20Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Tiemann Model Foley Catheter Coude Tip 30cc Balloon Red Latex Radiopaque Lubricious Coated · Class 2
All models of Bardex Lubricath Foley Catheter Tiemann Model Coude (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741018206), received between Nov 22, 2021 and Feb 23, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Deformation Due to Compressive Stress1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 23, 2023Deformation Due to Compressive Stress; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, PATIENT DID NOT AGREE THAT THE BENEFITS OF USING THE BARD/BECTON DICKINSON BIOCATH PRODUCT OUTWEIGH THE POTENTIAL RISKS BECAUSE IT MIGHT GET IN A KNOT IN RELATION TO TIEMANN MODEL, LUBRICATH, 2-WAY, 30CC BALLOON, FRENCH SIZE 20.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16427486 ↗MalfunctionNov 22, 2021Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT CONSISTENT AND THE TIPS WERE DIFFERENT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12858077 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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