Dover 400614 (UDI 10884521008908)Recalls & reported problems
Cardinal Health, Inc. · Vinyl Urethral Catheter · Class 2
All models of Dover (90)
Data updated Oct 16, 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 10884521008908), received between Mar 31, 2021 and May 7, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component1
- Material Twisted/Bent1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 7, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THEY OPENED A BOX AND A CATHETER IN THE BOX WAS BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21980357 ↗MalfunctionMar 31, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE PATIENT HAS BEEN USING THIS TYPE OF CATHETER FOR A NUMBER OF YEARS. A FEW DAYS AGO, HE WAS MET WITH PAIN AND BLEEDING AFTER INSERTION. AFTERWARDS, HE NOTICED THAT THE END OF THE CATHETER WAS GONE AND WHAT WAS LEFT WAS A SHARP EDGE. ALL OTHER CATHETERS IN THIS PARTICULAR BOX APPEAR TO BE INTACT AT THIS TIME. ADDITIONAL INFORMATION PROVIDED ON APRIL 13, 2021 STATED THAT THE PATIENT WAS USING THE URETHRAL CATHETER AT HOME AT THE TIME OF THE EVENT. THERE WERE NO CLEANING AGENTS USED ON THE DEVICE AS THIS IS A SINGLE USE CATHETER. WHEN THE PATIENT INSERTED THE CATHETER, IT IMMEDIATELY HURT. HE THEN URINATED AND PULLED IT OUT AS USUAL AND NOTICED THAT THERE WAS BLOOD ON THE CATHETER AND THE VERY END OF THE CATHETER WAS MISSING. THERE WAS NO WAS NO NEED FOR MEDICAL INTERVENTION. THE PATIENT IS DOING FINE AND THE TRAUMA HAS COMPLETELY CLEARED UP.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain
MAUDE report 11599237 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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