Bardex® Lubricath® Foley Catheter Tiemann Model Coude 0103L16Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741018183), received between Oct 3, 2017 and Dec 2, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Inflation Problem1
- Material Fragmentation1
- Material Puncture/Hole1
- Mushroomed1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Inflation Problem; Inflation Problem
IT WAS REPORTED THAT WHILE INFLATING THE FOLEY CATHETER BALLOON, WRITER OBSERVED A BALLOON FORMING ON THE WALL OF THE CATHETER OUTSIDE OF THE PENIS. BALLOON AT END OF CATHETER DID NOT INFLATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23696403 ↗MalfunctionSep 24, 2022Material Fragmentation; Material Puncture/Hole; Material Fragmentation; Material Puncture/Hole
IT WAS REPORTED THAT SILICON FOLEY CATHETER TIP WAS DANGLING AND FELL OFF.(MATERIAL#165816) AS PER FOLLOW UP VIA PHONE ON 23AUG2022, STATED THAT DEFECT WAS NOTICED UPON OPENING THE PACKAGE. BASED ON THE ORIGINAL FOLLOW UP MAIL, IT WAS STATED THAT THERE WAS THE ISSUE WITH THE CATHETER AND BOTH THE PIECES WERE RETURNED(MATERIAL#0103L16)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15475892 ↗MalfunctionJan 20, 2022Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE FOLEY CATHETERS CLOG UP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13308683 ↗MalfunctionOct 3, 2017Mushroomed
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER MUSHROOMED DURING PRETESTING.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6913166 ↗
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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