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Dover 13718Recalls & reported problems

Cardinal Health, Inc. · Silicone Coated Latex Foley Catheter,Pre-connected Drainage Bag · 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 10884521051539), received between Nov 12, 2019 and Nov 12, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

  • Deflation Problem1

Patient problems

  • Pain1

Recent adverse event reports

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

  • MalfunctionNov 12, 2019Deflation Problem; Deflation Problem

    THE CUSTOMER REPORTED THAT DURING AN ABLATION PROCEDURE, THE CATHETER'S BALLOON WAS DEFLATED AND VERIFIED BY THE PHYSICIAN. DIFFICULTY OF WITHDRAWAL OF THE PROBE WAS NOTED AND WHEN IT WAS REMOVED THEY FOUND THAT THE BALLOON WAS SLIGHTLY INFLATED. A LITTLE BLEEDING WAS NOTED AT THE LEVEL OF THE MEATUS AND PAIN WAS NOTED BY THE PATIENT.

    Patient problems: Pain

    MAUDE report 9309538 ↗

Other COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices

All COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER devices →

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