Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0102L22Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Tiemann Model Foley Catheter Coude Tip 5cc 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 00801741018152), received between Jan 3, 2023 and Jan 9, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Inadequate or Insufficient Training” (2 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, 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
- Inadequate or Insufficient Training2
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.
MalfunctionJan 9, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, AND THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD/BECTON DICKINSON PRODUCT(S) PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCT(S) AND ITS MEDICAL APPLICATION BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO CARSON MODEL, LUBRICATH®, 2-WAY, 5CC BALLOON, FRENCH SIZE 22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16120730 ↗MalfunctionJan 3, 2023Inadequate or Insufficient Training; Inadequate or Insufficient Training
IT WAS REPORTED THAT THE SURVEY RESPONDENT STATED NO, THEY DID NOT AGREE THAT THE INSTRUCTIONS FOR USE (IFU) FOR THE FOLLOWING BARD OR BECTON DICKINSON PRODUCTS PROVIDES SUFFICIENT INFORMATION ABOUT THE PRODUCTS AND THEIR MEDICAL APPLICATIONS BECAUSE THE INSTRUCTIONS FOR USE (IFU) HAD INADEQUATE INSTRUCTIONS FOR HEALTHCARE PROCESSIONAL AND INADEQUATE OR INSUFFICIENT TRAINING IN RELATION TO CARSON MODEL, LUBRICATH, 2-WAY, 5CC BALLOON, FRENCH SIZE 22.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16086604 ↗
Other CATHETER, COUDE devices
- Bardex® Lubricath® Foley Catheter 0165L14C. R. Bard, Inc. · CATHETER, COUDE562 reports
- Bardex® Lubricath® Foley Catheter 0165L16C. R. Bard, Inc. · CATHETER, COUDE539 reports
- Bardia® Foley Catheter Silicone Coated 123516AC. R. Bard, Inc. · CATHETER, COUDE381 reports
- Bardia® Foley Catheter Silicone Coated 123514AC. R. Bard, Inc. · CATHETER, COUDE195 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A899916C. R. Bard, Inc. · CATHETER, COUDE3 recalls19 reports
- Bardia® Foley Catheter Silicone Coated 123518AC. R. Bard, Inc. · CATHETER, COUDE153 reports
- SureStep™ Foley Tray System Bardex® Lubricath® Foley Catheter A902916C. R. Bard, Inc. · CATHETER, COUDE2 recalls50 reports
- Bard® Lubricath® Foley Catheter 365716C. R. Bard, Inc. · CATHETER, COUDE117 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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