Shiley 86454Recalls & reported problems

Covidien LP · Hi-Lo Oral/Nasal Tracheal Tube Cuffed,Intermediate, Murphy Eye · Class 2

All models of Shiley (387)

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

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884522000505), received between Apr 2, 2019 and Nov 11, 2019 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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.

Most reported problems

Device problems

Gas/Air Leak2
Inflation Problem1

Patient problems

Extubate2
No Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionNov 11, 2019Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE HAD A SECONDARY LEAKING CUFF/PILOT BALLOON.
Patient problems: No Information
MAUDE report 9307031 ↗
InjuryNov 7, 2019Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, THE DEVICE'S PILOT BALLOON WAS LEAKING AND THEY HAD TO REPLACE IT.
Patient problems: Extubate
MAUDE report 9293395 ↗
InjuryApr 2, 2019Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, THE DEVICE'S CANNULA BALLOON WAS BROKE. THE PATIENT REQUIRED A RE-INTUBATION.
Patient problems: Extubate
MAUDE report 8476253 ↗

Device details

UDI-DI	`10884522000505`
Brand	Shiley
Model	86454
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K965132
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): Basic endotracheal tube, single-use

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated; it does not include an antimicrobial agent(s). The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Other Tube, tracheal (w/wo connector) devices

Shiley 18875
Covidien LP · Tube, tracheal (w/wo connector)
4 deaths570 reports
RUSCH IPN041476
Teleflex Incorporated · Tube, tracheal (w/wo connector)
10 recalls0 reports
Shiley 18775
Covidien LP · Tube, tracheal (w/wo connector)
489 reports
Shiley 18770
Covidien LP · Tube, tracheal (w/wo connector)
2 deaths434 reports
Shiley 18880
Covidien LP · Tube, tracheal (w/wo connector)
2 deaths370 reports
Shiley 18780
Covidien LP · Tube, tracheal (w/wo connector)
3 deaths286 reports
Shiley 18770S
Covidien LP · Tube, tracheal (w/wo connector)
273 reports
Shiley 18780S
Covidien LP · Tube, tracheal (w/wo connector)
251 reports

All Tube, tracheal (w/wo connector) 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.

How reports and recalls are matched · Editorial policy · Report an error on this page