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Dover 8888492041 (UDI 10192253030341)Recalls & reported problems

Cardinal Health 200, LLC · DOVER URETHRAL PVC CATHETER, INTEGRAL FUNNEL, SMOOTH ROUNDED TIP, 14 FR (4.7 MM) X 16" · Class 2

Adverse event reports
13
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10192253030341), received between Oct 31, 2024 and Dec 22, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (13 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: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 1 reportsFeb 2025: 1 reportsMar 2025: 2 reportsApr 2025: 0 reportsMay 2025: 1 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 2 reportsDec 2025: 1 reportsJan 2026: 0 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 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Twisted/Bent13

Patient problems

  • No Clinical Signs, Symptoms or Conditions12
  • Hemorrhage/Blood Loss/Bleeding1

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT AND TWISTED, AND SHE COULD NOT USE THEM. THERE WAS NO REPORTED HARM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23863244 ↗
  • MalfunctionNov 20, 2025Material Twisted/Bent; Material Twisted/Bent

    PER CUSTOMER, PATIENT STATED THAT CATHETERS WERE BENT AND UNUSABLE. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23610040 ↗
  • MalfunctionNov 3, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETER TIPS WERE CRACKED AND BENT UP ON THE ENDS. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23453123 ↗
  • MalfunctionOct 24, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THEY HAVE A CURVE AND DAMAGE IN THE UPPER PART, PREVENTING THEM FROM FUNCTIONING CORRECTLY. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23383273 ↗
  • MalfunctionSep 18, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT AND TWISTED WHEN HE TOOK THEM OUT OF THE BOX. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23086509 ↗
  • MalfunctionJun 19, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE PATIENT SAID THAT SHE RECEIVED ONE BENT CATHETER MAKING IT UNUSABLE. THE PATIENT HAS USED THIS PRODUCT BEFORE. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22293678 ↗
  • MalfunctionJun 19, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE PATIENT SAID HE FOUND THREE CATHETERS BENT AND UNUSABLE. THE PATIENT HAS USED THIS PRODUCT BEFORE. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22289807 ↗
  • MalfunctionMay 23, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETER TIP WAS BENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22081910 ↗
  • MalfunctionMar 21, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE PATIENT STATED THAT CATHETERS WERE BENT AT THE TIP. THE PATIENT HAS USED THIS PRODUCT BEFORE. THERE WAS NO PATIENT HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21665498 ↗
  • MalfunctionMar 21, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE PRODUCT IN THE BOX WAS DEFECTIVE, TIP OF THE CATHETERS WAS BENT BECAUSE OF THE WAY IT WAS PACKAGED. THE CUSTOMER TRIED TO USE THE PRODUCT, BUT IT CAUSED BLEEDING. THE CUSTOMER ORDERS THIS ITEM REGULARLY AND NEVER EXPERIENCED ISSUES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO MEDICAL INTERVENTION OR TREATMENT REQUIRED.

    Patient problems: Hemorrhage/Blood Loss/Bleeding

    MAUDE report 21665209 ↗
  • MalfunctionFeb 4, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETERS WERE BENT AT THE TIPS, MAKING THEM UNABLE TO USE. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21305443 ↗
  • MalfunctionJan 29, 2025Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE CATHETERS WERE DEFECTIVE, NOT WORKING AND SOME WERE EVEN BENT AND TWISTED. THERE WAS NO HARM REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21266741 ↗
  • MalfunctionOct 31, 2024Material Twisted/Bent; Material Twisted/Bent

    THE CUSTOMER REPORTED THAT THE TIPS OF THE CATHETERS WERE BENT BEYOND SAFE USAGE. THE ISSUE WAS OBSERVED BEFORE USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20577428 ↗

Other CATHETER, UROLOGICAL devices

All CATHETER, UROLOGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.