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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 3 reportsNov 2024: 3 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 1 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

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 ↗

Other CATHETER, UROLOGICAL devices

All CATHETER, UROLOGICAL devices →

Sources and updates

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