Dover 400614 (UDI 10192253029109)Recalls & reported problems
Cardinal Health 200, LLC · DOVER VINYL URETHRAL CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 14 FR (4.7 MM) · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10192253029109), received between Oct 24, 2024 and Jan 22, 2026 — classified as 1 injury, 8 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (9 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/Bent9
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Pain1
- Urinary Tract Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 22, 2026Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT IN THE BOX THAT ARE CURVED AND REMAIN CURVED WHEN HE TAKES THEM OUT OF THE BOX, AND THEY DID NOT HAVE THE ORIGINAL STRAIGHT SHAPE. THE CLIENT MENTIONED THAT CAUSES PROBLEMS WITH INSERTION (DIFFICULT) BECAUSE THE CATHETER MUST BE STRAIGHT AS ORIGINALLY, BUT IT REMAINS CURVED BY A BAD FOLD IN THE BOX. THERE WAS NO PATIENT HARM REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24157500 ↗MalfunctionMar 24, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT A BOX WAS OPENED AND SOME IN THE BOX WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21679227 ↗MalfunctionJan 6, 2025Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE CURVED DUE TO THE PACKAGING BEING TOO SMALL FOR THE LENGTH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21078746 ↗MalfunctionNov 20, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE TIP OF THE CATHETERS WERE BENT INSIDE THE BOX AND THEY COULDN'T INSERT WITHOUT CAUSING PAIN.
Patient problems: Pain
MAUDE report 20736055 ↗MalfunctionNov 12, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20662448 ↗MalfunctionNov 7, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20633731 ↗MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS RECEIVED WERE BENT/DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570819 ↗MalfunctionOct 30, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT THE CATHETERS RECEIVED WERE BENT/DEFECTIVE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20570693 ↗InjuryOct 24, 2024Material Twisted/Bent; Material Twisted/Bent
THE CUSTOMER REPORTED THAT SOME OF THE CATHETERS ARE BENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT HE HAS EXPERIENCED URINARY TRACT INFECTION (UTI) BECAUSE OF THE BENT CATHETERS, AND HE WENT TO THE PHYSICIAN AND THE PHYSICIAN HAS PRESCRIBED CEPHALEXIN 500MG. HE HAS A FOLLOW-UP APPOINTMENT ON (B)(6) 2024 AFTERNOON.
Patient problems: Urinary Tract Infection
MAUDE report 20529219 ↗
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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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