Shiley 5CN70ESRecalls & reported problems

Covidien LP · Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff Single Cannula - No Inner Cannula · Class 2

All models of Shiley (387)

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

Adverse event reports: 7
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10884521726406), received between Oct 26, 2023 and Oct 27, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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

Material Split, Cut or Torn7

Patient problems

Insufficient Information7

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18025060 ↗
MalfunctionOct 27, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18024998 ↗
MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18015711 ↗
MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18014764 ↗
MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18014699 ↗
MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18014682 ↗
MalfunctionOct 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, THE CUFF OF THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING USING A CUFF CONTROLLER. ANOTHER CANNULA WAS USED WITHOUT A PROBLEM. THERE WAS NO PATIENT INJURY. THE OTHER SEVEN TUBES REPORTED HAD A CUFF ISSUE AND IT WAS UNKNOWN IF THERE IS PATIENT INVOLVEMENT AT THE TIME OF THE ISSUE REPORTED.
Patient problems: Insufficient Information
MAUDE report 18014659 ↗

Device details

UDI-DI	`10884521726406`
Brand	Shiley
Model	5CN70ES
Company	Covidien LP
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K193077
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 24, 2025

Device type (GMDN): Tracheostomy tube, non-reinforced, non-customized, single-use

A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Other Tube tracheostomy and tube cuff devices

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All Tube tracheostomy and tube cuff 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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