Bard® Foley Catheter Silicone Coated 265722Recalls & reported problems
C. R. Bard, Inc. · Bard®Foley Catheter, Silicone Coated, 5cc Balloon · Class 2
All models of Bard Foley Catheter Silicone Coated (10)
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 00801741039621), received between Mar 5, 2021 and Apr 26, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Decrease in Pressure” (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
- Decrease in Pressure1
- Partial Blockage1
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.
MalfunctionApr 26, 2021Decrease in Pressure; Decrease in Pressure
IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH THE FOLEY CATHETER. THE PATIENT STATED THE BALLOON WAS DEFLATING AND THE CATHETER WAS SLIDING OUT. ALSO STATED THE PATIENT WOULD KEEP THE FOLEY CATHETER IN A DRAIN BAG AND WOULD TRY WITH OTHERS TO SEE IF IT DEFLATES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11723704 ↗MalfunctionMar 5, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT SEVERAL FOLEY CATHETERS GOT CLOGGED SO PATIENT HAD TO GO TO THE EMERGENCY ROOM TO GET IT CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11422291 ↗
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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