Bardex® Urethral Catheter Robinson Model 056118Recalls & 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
- 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 00801741033544), received between Aug 23, 2019 and Apr 1, 2022 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (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
- Tear, Rip or Hole in Device Packaging2
- Break1
- Crack1
- Device Damaged Prior to Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 1, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF 2 INTERMITTENT CATHETERS WERE RIPPED AND HENCE, THE CATHETERS BECAME UNSTERILE. PER SAMPLE RECEIVED ON 08MAR2022, IT WAS NOTED THAT THE INTERMITTENT CATHETERS WERE RETURNED FOR EVALUATION. PER ADDITIONAL INFORMATION RECEIVED VIA SAMPLE FORM ON 15MAR2022, CUSTOMER STATED THAT THE WRAPPER OF THE INTERMITTENT CATHETERS HAD TEARS WHICH RESULTED IN THE CATHETERS BECOMING UNSTERILE. IT WAS STATED THAT THE SECOND CATHETER HAD THE SAME RESULT AND NO FURTHER ISSUES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13980173 ↗MalfunctionMar 9, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED THAT THE PACKAGING OF 2 INTERMITTENT CATHETERS WERE RIPPED AND HENCE, THE CATHETERS BECAME UNSTERILE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13710268 ↗MalfunctionAug 23, 2019Break; Crack; Device Damaged Prior to Use; Break
IT WAS REPORTED THAT RUBBER ON THE CATHETER WAS CRACKING WHICH WAS NOTED PRIOR TO USE.
Patient problems: No Patient Involvement
MAUDE report 8926358 ↗
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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