Dover 8888492025Recalls & reported problems
Cardinal Health 200, LLC · DOVER URETHRAL PVC CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 10 FR (3.3 MM) X 16" · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10192253030327), received between Mar 14, 2025 and Apr 7, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent2
- Detachment of Device or Device Component1
- Nonstandard Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Foreign Body In Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Nonstandard Device
THE CUSTOMER REPORTED THAT THEY WERE UNABLE TO PERFORM A STRAIGHT CATHETER ON A PATIENT DUE TO NO HOLE IN THE TIP OF THE CATHETER. THERE WAS NO HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24802509 ↗MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED BENT CATHETERS. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23452714 ↗InjuryJun 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED THAT THE CATHETER WAS BROKEN IN HALF AND SOME PIECES DETACHED FROM THE TIP. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THE ISSUE WAS DISCOVERED AFTER USED ON A PATIENT. IT WAS INTACT IN THE PACKAGE. PER CUSTOMER, PROBABLY PIECES WERE LEFT IN PATIENT, BUT NO WAY TO KNOW IF THERE WAS STILL PIECES LEFT. THERE WAS NO HARM KNOWN AT THIS TIME.
Patient problems: Foreign Body In Patient
MAUDE report 22187781 ↗MalfunctionMar 14, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT INADEQUATE PACKAGING OF THE CATHETERS, WHICH RESULTED IN SIGNIFICANT DAMAGE TO THE PRODUCT. SPECIFICALLY, THEY HAVE FOUND THAT THE TIPS OF THE CATHETERS WERE OFTEN BENT TO THE POINT THAT THEY BECOME UNUSABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21608245 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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