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Dover 8403Recalls & reported problems

Cardinal Health, Inc. · Red Rubber Urethral Catheter,Coude Tip · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884521015740), received between Dec 11, 2020 and Dec 11, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Obstruction of Flow” (1 report).

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.

Most reported problems

Device problems

  • Obstruction of Flow1

Patient problems

  • Burning Sensation1
  • Hemorrhage/Blood Loss/Bleeding1
  • Pain1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 11, 2020Obstruction of Flow; Obstruction of Flow

    THE CUSTOMER REPORTED THAT THEY USE THESE CATHETERS TO EMPTY THEIR BLADDER THROUGH A HOLE IN THEIR NAVEL DUE TO BLADDER CANCER. THEIR BLADDER AND URETHRA WERE REMOVED AND A NEW BLADDER WAS BUILT USING TISSUE FROM THEIR INTESTINE AND PART OF THEIR APPENDIX WAS USED TO BUILD A PIPE FROM THEIR BLADDER TO THEIR NAVEL. THEIR NAVEL HAS BEEN PIERCED AND IT IS BY INSERTING THE CATHETER THROUGH THE NAVEL INTO THE TUBE THAT THEY CAN EMPTY THEIR BLADDER. TYPICALLY THEY DO THIS FOUR TO FIVE TIMES A DAY. FOR SOME TIME NOW THEY HAVE BEEN NOTICING SOME INCONSISTENCIES IN THE QUALITY OF THE PRODUCT. INCONSISTENCIES IN THE SIZE OF THE TIP THAT PENETRATE THE OPENING OF THE NAVEL HAVE BEEN OBSERVED. WHEN LARGER THAN USUAL, THE TIP HAS DIFFICULTY PENETRATING AND CAUSES PAIN AND SOMETIMES BLEEDING. INCONSISTENCIES IN THE SIZE OF THE EYELETS HAVE ALSO BEEN OBSERVED. WHEN THEY ARE TOO SMALL, URINE MAY NOT PASS BECAUSE PIECES OF MUCUS ARE BLOCKING THE EYELETS. WHEN THE EYES ARE TOO LARGE, THEY RUB AGAINST THE INNER TISSUE OF THE TUBE CAUSING AN UNPLEASANT FEELING OF HEATING AND SOMETIMES BLEEDING AS WELL. INCONSISTENCIES IN THE HARDNESS OF THE CATHETER HAVE ALSO BEEN OBSERVED. WHEN THE CATHETER IS TOO SOF

    Patient problems: Burning Sensation; Hemorrhage/Blood Loss/Bleeding; Pain

    MAUDE report 10992956 ↗

Other CATHETER, URETHRAL devices

All CATHETER, URETHRAL devices →

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