Bardex® Lubricath® Foley Catheter Coleman Model 6016L22Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Coleman Model 3 Way Foley Catheter Red Latex Radiopaque 40cc, 20cc Balloons Lubricous Coated · Class 2
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 00801741019111), received between Sep 14, 2022 and Sep 16, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled2
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.
MalfunctionSep 16, 2022Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE FOLEY CATHETER WHICH THE CUSTOMER RECEIVED HAD ONLY 1 PORT TO CONTROL THE 2 BALLOONS. REPRESENTATIVE DESCRIBED THAT THE FOLEY CATHETER SHOULD HAVE TWO PORTS FOR TWO BALLOON INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15437167 ↗MalfunctionSep 14, 2022Component Misassembled; Component Misassembled
IT WAS REPORTED THAT THE FOLEY CATHETER THE CUSTOMER RECEIVED ONLY HAD 1 PORT TO CONTROL THE 2 BALLOONS. REPRESENTATIVE DESCRIBED THAT THE FOLEY CATHETER SHOULD HAVE TWO PORTS FOR TWO BALLOON INFLATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15417050 ↗
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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