Bardex® Urethral Catheter Robinson Model 056108Recalls & reported problems
C. R. Bard, Inc. · Bardex® Urethral Catheter Robinson Model · Class 2
All models of Bardex Urethral Catheter Robinson Model (8)
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 00801741033490), received between Apr 29, 2024 and Apr 7, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (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
- Incorrect Measurement1
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 7, 2026
STAFF OPENED A CATHETER PACKAGE AND NOTICED THAT THE CATHETER MATERIAL APPEARED FADED AND CRACKED. THEY DID NOT USE THE CATHETER AND CHOSE ANOTHER PRODUCT THAT PASSED A VISUAL INSPECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24799643 ↗MalfunctionApr 29, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT LOT#NGHY0765 WAS SUPPOSED TO BE 8FR INTERMITTENT CATHETER BUT WHEN COMPARED TO OTHER 8FR WITH DIFFERENT LOT#¿S THESE WERE BIGGER THAN AN 8FR. PER FOLLOW UP VIA EMAIL RESPONSE ON 21MAY2024, IT WAS REPORTED THAT THE DEFECT WAS NOTICED BEFORE USE AND NO PATIENT HARM WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19200518 ↗
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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