Shiley 86237 (UDI 10884521619937)Recalls & reported problems

Covidien LP · Oral/Nasal Tracheal Tube Cuffless Non DEHP, Murphy Eye · Class 2

All models of Shiley (387)

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

Adverse event reports: 10
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521619937), received between Sep 6, 2019 and Sep 6, 2019 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Defective Component” (10 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

Defective Component10

Patient problems

No Patient Involvement10

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970865 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS STATED THAT IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970857 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970854 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970851 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970757 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970756 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970753 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970747 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970425 ↗
MalfunctionSep 6, 2019Defective Component; Defective Component
ACCORDING TO THE REPORTER, THE DEVICE HAD A STICKY RESIDUE AT THE END OF THE TUBE. IT WAS CLOUDY AND HAD A ROUGH SURFACE ALL THROUGHOUT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8970419 ↗

Device details

UDI-DI	`10884521619937`
Brand	Shiley
Model	86237
Company	Covidien LP
Product code	BTR · Tube, tracheal (w/wo connector)
Class	Class 2
FDA submission	K151381
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Safe
Status	In Commercial Distribution
Record updated	Apr 9, 2026

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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