Shiley 70XLTUPRecalls & reported problems

Covidien LP · Tracheostomy Tube XLT Cuffless,Proximal with Disposable Inner Cannula · 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: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884522025096), received between Feb 28, 2025 and Feb 28, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

Reports received per month

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

Most reported problems

Device problems

Gas/Air Leak1

Patient problems

Unintended Extubation1

Recent adverse event reports

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

MalfunctionFeb 28, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THERE WAS AN AIR LEAKAGE IN THE CUFF ON BOTH THE 7.0MM TRACH CUFF AND THE 7.0MM UNCUFF TRACH AT A HOSPITAL. THE TRACH WERE REPLACED EVERY TIME IT FAILED. EVENTUALLY, A DIFFERENT MANUFACTURER TRACHEOSTOMY WAS PLACED WITHOUT INCIDENT. TRACHEOSTOMY TUBE REMAINED IN PLACE UNTIL A PLANNED TRACH CHANGE WAS DONE.
Patient problems: Unintended Extubation
MAUDE report 21494282 ↗

Device details

UDI-DI	`10884522025096`
Brand	Shiley
Model	70XLTUP
Company	Covidien LP
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K051416
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
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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