Bardex® Lubricath® Foley Catheter 0125RL20Recalls & reported problems
C. R. Bard, Inc. · Bardex® Lubricath® Foley Catheter Red Latex Radiopaque 30cc 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741019159), received between Apr 3, 2023 and Apr 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Inadequate Instructions for Healthcare Professional” (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
- Inadequate Instructions for Healthcare Professional1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 3, 2023Inadequate Instructions for Healthcare Professional; Inadequate Instructions for Healthcare Professional
IT WAS REPORTED THAT CUSTOMER WAS STATING THAT THIS WAS NOT A 3 WAY AND NEEDS ITEM RETURN. PER FOLLOW UP VIA PHONE (B)(6)2023, THERE WAS NO ISSUE WITH THE PRODUCT ITSELF. CUSTOMER STATED THE DISTRIBUTOR HAD THE PRODUCT LISTED INCORRECTLY ON THE SITE FOR ORDERING. PER SAMPLE FORM RECEIVED ON (B)(6)2023, IT WAS REPORTED THAT THE MEDLINE DISTRIBUTOR HAD A 3 WAY CATHETER LISTED AS A 2 WAY CATHETER ON MEDLINES WEBSITE. ALSO STATED THAT THEY NEVER FILED A REPORT WITH BD AND THAT THEY FILED WITH MEDLINE TO FIX THE ITEM DESCRIPTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16662990 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page