Shiley 3.0NCF (UDI 10884521103467)Recalls & reported problems

Covidien LP · Neonatal Tracheostomy Tube with TaperGuard Cuff · Class 2

All models of Shiley (387)

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521103467), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 injury.

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

Most reported problems

Device problems

Defective Component1

Patient problems

Low Oxygen Saturation1
Unintended Extubation1

Recent adverse event reports

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

InjuryJan 5, 2022Defective Component; Defective Component
ACCORDING TO THE REPORTER, AFTER TWO DAYS OF THE DEVICE'S USAGE, THE PATIENT HAD TO BE RESUSCITATED DUE TO DIMENSIONAL ISSUES. THE HEALTHCARE PROFESSIONAL STATED THAT THE NEW DEVICE'S ANGLE HAD A BIG DIFFERENCE FROM THE OLD WHICH WAS NOT SUITABLE FOR SOME PATIENTS BECAUSE OF TOO HIGH PRESSURE TO ONE SIDE OF THE TRACHEA. PERFORMED MANUAL VENTILATION AND REPLACEMENT OF THE TUBE.
Patient problems: Low Oxygen Saturation; Unintended Extubation
MAUDE report 13168014 ↗

Device details

UDI-DI	`10884521103467`
Brand	Shiley
Model	3.0NCF
Company	Covidien LP
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K182861
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Tracheostomy tube, non-reinforced, non-customized, single-use

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

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All Tube tracheostomy and tube cuff 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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