Shiley 18865SRecalls & reported problems

Covidien LP · TaperGuard Evac Oral Tracheal Tube with Stylet 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 10884521726680), received between Sep 4, 2024 and Nov 17, 2025 — classified as 2 malfunctions.

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
Use of Device Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Unintended Extubation1

Recent adverse event reports

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

MalfunctionNov 17, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT INTRA-OPERATIVELY, IMMEDIATELY AFTER INTUBATION, THE ENDOTRACHEAL TUBE'S CUFF HAD AN AIR LEAK. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 23569798 ↗
MalfunctionSep 4, 2024Use of Device Problem; Use of Device Problem
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CUFF OF THE ENDOTRACHEAL TUBE DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20138456 ↗

Device details

UDI-DI	`10884521726680`
Brand	Shiley
Model	18865S
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K090352
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Apr 10, 2026

Device type (GMDN): Cuff-suction endotracheal tube

A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

Other Tube, tracheal (w/wo connector) devices

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4 deaths570 reports
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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
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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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