Bardex® Lubricath® Foley Catheter 01237522Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter 75cc Balloon Medium Length Round Tip 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
- 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 00801741017735), received between Dec 8, 2017 and Mar 27, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (3 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
- Burst Container or Vessel3
- Material Puncture/Hole2
- Deflation Problem1
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 27, 2024Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT CUSTOMER HAD A DEFECTIVE FOLEY CATHETER THAT POPPED WHEN IT WAS USED ON A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18985450 ↗MalfunctionMar 22, 2024Burst Container or Vessel; Material Puncture/Hole; Burst Container or Vessel; Material Puncture/Hole
IT WAS REPORTED THAT BALLOON OF FOLEY CATHETER POPPED WHILE INSERTING INTO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18958781 ↗MalfunctionDec 20, 2019Deflation Problem; Deflation Problem; Fluid/Blood Leak; Material Puncture/Hole
IT WAS REPORTED THAT WHEN THE NURSE PLACED THE FOLEY IN AND INFLATED THE BALLOON, THE BALLOON HAD A HOLE AND WAS LEAKING.AT FIRST THEY THOUGHT IT WAS THE PATIENT¿S URINE LEAKING FROM THE SIDE OF THE TUBE, BUT THEN THEY REALIZED IT WAS THE NORMAL SALINE WATER THAT THEY USED TO INFLATE THE BALLOON WAS LEAKING.
Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient
MAUDE report 9503148 ↗MalfunctionDec 8, 2017Burst Container or Vessel
IT WAS REPORTED THAT THE BALLOON OF THE CATHETER BURST.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7101567 ↗
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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