Dover 8887605122Recalls & reported problems

Cardinal Health, Inc. · 100% Silicone Foley Catheter,5 mL, 2-Way · 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 10884521016651), received between Sep 17, 2024 and Sep 17, 2024 — classified as 1 malfunction.

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

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Unintended Deflation1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionSep 17, 2024Unintended Deflation; Unintended Deflation
THE CUSTOMER REPORTED THAT THE CATHETER WAS LEAKING FROM THE HOLE ON BALLOON ARM. THE ISSUE WAS FOUND AFTER THE CATHETER WAS ALREADY PLACED IN PATIENT AND THE CATHETER HAD TO BE REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20241599 ↗

Device details

UDI-DI	`10884521016651`
Brand	Dover
Model	8887605122
Company	Cardinal Health, Inc.
Product code	FCM · Tray, catheterization, sterile urethral, with or without catheter (kit)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Dec 31, 2025

Device type (GMDN): Indwelling urethral drainage balloon catheter, non-antimicrobial

A flexible tube with an inflatable balloon at its distal tip intended to be inserted through the urethra and retained in the urinary bladder, or prostatic bed, of an adult or paediatric patient to function as an indwelling therapeutic device for urinary drainage; it might also be designed for infusion of fluids (irrigation). It may have a bent tip (coude) to facilitate insertion, and some types may be provided with a guidewire to facilitate difficult insertion (e.g., in cases of enlarged prostate); it does not include an antimicrobial agent(s). Most types are commonly known as a Foley catheter; it is intended to be introduced by a healthcare professional. This is a single-use device.

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All Tray, catheterization, sterile urethral, with or without catheter (kit) devices →

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