Dover 8887605189 (UDI 00884521166649)Recalls & reported problems

Cardinal Health, Inc. · 100% Silicone Foley Catheter,5-10 mL, 2-Way · Class 2

All models of Dover (90)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884521166649), received between Nov 4, 2024 and Nov 6, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Rupture4

Patient problems

No Clinical Signs, Symptoms or Conditions4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 6, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. THREE OCCURRENCES WERE REPORTED FOR LOT NUMBER 23B097FHX, THIS CASE REPRESENTS #3 OF THE 3 REPORTED CASES. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20620144 ↗
MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. LOT NUMBER 23B097FHX. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20602270 ↗
MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. LOT NUMBER 123K165FHX. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20601825 ↗
MalfunctionNov 4, 2024Material Rupture; Material Rupture
CUSTOMER REPORTS: THE BALLOON ON THE CATHETER SNAPPED (BURST). SOMETIMES IMMEDIATELY AFTER INSERTION, OTHER TIMES 2-3 DAYS AFTER INSERTION. THE END-USER'S URINE IS CLEAN AND HAS NO GRIT. THREE OCCURRENCES WERE REPORTED FOR LOT NUMBER 23B097FHX, THIS CASE REPRESENTS # 2 OF THE 3 REPORTED CASES. THE BALLOON WAS REMOVED AS PER NORMAL PROCEDURE AND THE CATHETER HAS BEEN REPLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20601261 ↗

Device details

UDI-DI	`00884521166649`
Brand	Dover
Model	8887605189
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, 2024

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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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