Shiley 86549Recalls & reported problems

Covidien LP · Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye · Class 2

All models of Shiley (387)

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

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521211650), received between Nov 26, 2018 and Apr 27, 2022 — classified as 2 malfunctions.

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
Gas/Air Leak1
Inflation Problem1
Use of Device Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1
No Information1
Unintended Extubation1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 27, 2022Use of Device Problem; Defective Component; Gas/Air Leak; Use of Device Problem; Defective Component; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING SURGERY, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 14225832 ↗
MalfunctionNov 26, 2018Inflation Problem; Inflation Problem
ACCORDING TO THE REPORTER, DURING THE PROCEDURE, THE DEVICE HAD CUFF INFLATION/DEFLATION ISSUE. THE CUSTOMER REPORTED THAT THE DEVICE WAS IN CONTACT WITH THE PATIENT'S AIRWAY AND SECRETIONS ARE IDENTIFIED IN THE PHOTO PROVIDED. THERE IS NO REPORTED PATIENT OUTCOME.
Patient problems: No Information
MAUDE report 8102835 ↗

Device details

UDI-DI	`10884521211650`
Brand	Shiley
Model	86549
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K790575
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): Laser-resistant endotracheal tube

A hollow cylinder that is inserted into the trachea used to secure airway patency and/or for anaesthesia administration, and which is not damaged or easily set on fire if inadvertently irradiated by a laser beam during surgery around the head, throat, or neck. This device would typically be employed when laser surgery is being applied to the patient's head/neck area. 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.

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