Bardex® Silicone Coated Foley Catheter 0165V20SRecalls & reported problems
C. R. Bard, Inc. · Bardex® Foley Catheter 5cc Balloon Silicone Coated · Class 2
All models of Bardex Silicone Coated Foley Catheter (13)
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 00801741039416), received between Jul 7, 2020 and Nov 18, 2022 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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
- Burst Container or Vessel1
- Failure to Infuse1
- Fluid/Blood Leak1
- Material Rupture1
- Partial Blockage1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient2
- Hemorrhage/Blood Loss/Bleeding1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 18, 2022Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT HAD LEAKING FROM THE 2-WAY FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15825358 ↗MalfunctionFeb 18, 2021Failure to Infuse; Failure to Infuse
IT WAS REPORTED THAT THE NURSE WAS UNABLE TO FILL THE BALLOON WITH LIQUID. THE PATIENT HAD TO OPEN ANOTHER CATHETER AND IRRIGATION TRAY. PER FOLLOW UP VIA PHONE ON 11FEB2021 THE NURSE TRIED 3 TIMES BUT THE BALLOON DID NOT INFLATE DURING INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11344056 ↗MalfunctionFeb 12, 2021Partial Blockage; Partial Blockage
IT WAS REPORTED THAT THE FOLEY CATHETER WAS CLOGGING.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11322226 ↗MalfunctionJul 7, 2020Burst Container or Vessel; Material Rupture; Burst Container or Vessel
IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED BALLOON BURST RESULTED IN BLEEDING. NO MEDICAL INTERVENTION WAS REPORTED.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Patient Problem/Medical Problem
MAUDE report 10240176 ↗
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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