Shiley 96360Recalls & reported problems

Covidien LP · Nasal RAE Tracheal Tube with TaperGuard Cuff,Murphy Eye · Class 2

All models of Shiley (387)

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

Adverse event reports: 6
Deaths reported: 0
Injuries reported: 3
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 40884521157447), received between Mar 20, 2020 and Dec 4, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (4 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.

Reports received per month

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

Most reported problems

Device problems

Gas/Air Leak4
Defective Component2

Patient problems

Extubate2
No Information2
Unintended Extubation2
Hypoventilation1
No Clinical Signs, Symptoms or Conditions1
No Consequences Or Impact To Patient1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

InjuryDec 4, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE'S CUFF WOULD NOT PROPERLY INFLATE DURING THE PROCEDURE. THERE WAS SIGNIFICANT CUFF LEAK AND COULD NOT ACHIEVE GOAL TIDAL VOLUMES. THE TUBE WAS REPLACED.
Patient problems: Hypoventilation; Unintended Extubation
MAUDE report 23723301 ↗
MalfunctionJun 17, 2025Defective Component; Defective Component
IT WAS REPORTED THAT INTRA-OPERATIVELY, THE PATIENT WAS INTUBATED USING NASAL TUBE FOR DENTAL PROCEDURE. TUBE HAD A KINK/BEND IN THE NOSE THAT WAS UNABLE TO BE SEEN. THE TUBE WAS REPLACED.
Patient problems: Unintended Extubation
MAUDE report 22229329 ↗
MalfunctionApr 29, 2024Defective Component; Defective Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, DURING NASOTRACHEAL INTUBATION, A PERFORATED TUBE'S CUFF WAS OBSERVED. IT WAS STATED THAT DUE TO THE ISSUE, THE BALLOON SHOULD BE UNCLOGGED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19204499 ↗
InjuryApr 10, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD LEAKED. THERE WAS NO PATIENT INJURY.
Patient problems: Extubate; No Consequences Or Impact To Patient
MAUDE report 9947633 ↗
MalfunctionMar 20, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD LEAKED. THERE WAS NO REPORTED PATIENT OUTCOME.
Patient problems: No Information
MAUDE report 9859581 ↗
InjuryMar 20, 2020Gas/Air Leak; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING USE, THE DEVICE'S CUFF HAD LEAKED. THE PATIENT REQUIRED REINTUBATION.
Patient problems: Extubate; No Information
MAUDE report 9859546 ↗

Device details

UDI-DI	`40884521157447`
Brand	Shiley
Model	96360
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K941246
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.

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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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