Bardex® Lubricath® Foley Catheter 0165L28Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter 5cc Balloon Lubricious Coated · Class 2
All models of Bardex Lubricath Foley Catheter (38)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741017544), received between Apr 20, 2020 and Nov 27, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement2
- Expiration Date Error1
- Material Puncture/Hole1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2023Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE PATIENT ORDERED FOLEY CATHETER AND THE CURRENT LOT RECEIVED WERE NOT THE CORRECT SIZE. PER ADDITIONAL INFORMATION RECEIVED VIA PHONE ON 13NOV2023, CUSTOMER EXPERIENCED A SIZING ISSUE. CUSTOMER THOUGHT THAT THE FOLEY CATHETER WAS SMALLER THAN THEY HAVE BEEN BEFORE, THE PACKAGING SAID 28 BUT CUSTOMER FELT THEY WERE GETTING 26. CUSTOMER STATED THAT THIS WAS FREQUENTLY HAPPENING TO WHERE THEY HAD AT LEAST ONE THE WRONG SIZE FROM EVERY ORDER, BUT THIS ORDER CUSTOMER HAD ABOUT 8 OF THEM. CUSTOMER STATED THAT THEY WERE ALL FROM THE SAME LOT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18209199 ↗MalfunctionMay 24, 2023Material Puncture/Hole; Material Puncture/Hole
IT WAS REPORTED THAT THE FOLEY CATHETER BALLOON WAS LEAKING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991947 ↗MalfunctionApr 20, 2020Incorrect Measurement; Expiration Date Error; Protective Measures Problem; Incorrect Measurement; Expiration Date Error
IT WAS REPORTED THAT THE CATHETER DIAMETER SEEMED TO BE OFF. ONE SIDE OF THE CATHETER MEASURED CORRECTLY, HOWEVER THE OTHER SIDE WAS OFF IN DIMENSION.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9978096 ↗
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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