Bardex® Silicone Coated Foley Catheter 0166V12SRecalls & reported problems
C. R. Bard, Inc. · Bardex® Foley Catheter 30cc 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
- 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 00801741039478), received between Nov 25, 2025 and Mar 9, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Disconnection” (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.
Reports received per month
Most reported problems
Device problems
- Disconnection1
- Inaccurate Flow Rate1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hematuria1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 9, 2026Inaccurate Flow Rate
IT WAS REPORTED THAT THAT URINE DID NOT FLOW TO THE BAG AFTER 2HRS INSERTED THE FOLEY CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24545349 ↗MalfunctionNov 25, 2025Disconnection; Disconnection
IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED ON (B)(6) 2025 WITH AN INDWELLING URINARY FOLEY CATHETER BROUGHT FROM ANOTHER HOSPITAL, WHICH HAD ALREADY EXPIRED UPON ADMISSION. THE INDWELLING CATHETER WAS REPLACED ON (B)(6) 2025. HEMATURIA DEVELOPED ON (B)(6) 2025 AND PERSISTS TO DATE. TODAY, THE CATHETER WAS ADJUSTED PER PHYSICIAN'S ORDERS. THE WATER INLET PORT WAS RECESSED, AND WATER FROM THE BLADDER COULD NOT BE WITHDRAWN USING A SYRINGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23646710 ↗MalfunctionNov 25, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT, THE PATIENT WAS ADMITTED ON (B)(6) 2025 WITH AN INDWELLING URINARY FOLEY CATHETER BROUGHT FROM ANOTHER HOSPITAL, WHICH HAD ALREADY EXPIRED UPON ADMISSION. THE INDWELLING CATHETER WAS REPLACED ON (B)(6) 2025. HEMATURIA DEVELOPED ON (B)(6) 2025 AND PERSISTS TO DATE. TODAY, THE CATHETER WAS ADJUSTED PER PHYSICIAN'S ORDERS. THE WATER INLET PORT WAS RECESSED, AND WATER FROM THE BLADDER COULD NOT BE WITHDRAWN USING A SYRINGE.
Patient problems: Hematuria
MAUDE report 23646688 ↗
Other CATHETER, UROLOGICAL devices
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50614C. R. Bard, Inc. · CATHETER, UROLOGICAL883 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53614GC. R. Bard, Inc. · CATHETER, UROLOGICAL692 reports
- Magic3™ Coude Intermittent Catheter with Sure-Grip™ Sleeve 50616C. R. Bard, Inc. · CATHETER, UROLOGICAL2 deaths443 reports
- GENTLECATH GLIDE 421567Convatec, Purchasing Department · Catheter, Urological342 reports
- Magic3™ Intermittent Catheter with Sure-Grip™ Sleeve 53616GC. R. Bard, Inc. · CATHETER, UROLOGICAL301 reports
- Bardex® Foley Catheter Silicone Coated 0167V22SC. R. Bard, Inc. · CATHETER, UROLOGICAL187 reports
- Bardex® Foley Catheter Silicone Coated 0167V20SC. R. Bard, Inc. · CATHETER, UROLOGICAL175 reports
- Bardia® Coude Olive Tip Urethral Foley Catheter 802516C. R. Bard, Inc. · CATHETER, UROLOGICAL170 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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