Dover 400612Recalls & reported problems
Cardinal Health 200, LLC · DOVER VINYL URETHRAL CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 12 FR (4.0 MM) · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253029093), received between Nov 5, 2024 and Jul 1, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (4 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent4
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 1, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THEY RECEIVED A BENT CATHETER. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22373963 ↗MalfunctionMar 11, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE COMING BENT AND NOT PACKED PROPERLY IN THE BOX. PER CUSTOMER, THE BOXES ARE IN PERFECT SHAPE, AND THE CATHETERS INSIDE ARE THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21573469 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT ITEMS RECEIVED WERE IN A DAMAGED/UNUSABLE CONDITION. THE CUSTOMER HAS CONFIRMED THAT THERE WAS NO DAMAGE TO OUTSIDE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETERS WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612310 ↗MalfunctionNov 5, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT ITEMS RECEIVED WERE IN A DAMAGED/UNUSABLE CONDITION. THE CUSTOMER HAS CONFIRMED THAT THERE WAS NO DAMAGE TO OUTSIDE PACKAGING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE CATHETERS WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20612021 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.