TRACOE twist REF 303-05Recalls & reported problems

Tracoe medical GmbH · Tracheostomy Tube · Class 2

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

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04035324034116), received between Mar 12, 2025 and Mar 12, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (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

Material Separation1
Mechanical Problem1

Patient problems

Hemorrhage/Blood Loss/Bleeding1
No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionMar 12, 2025Mechanical Problem; Material Separation; Mechanical Problem; Material Separation
1) WHAT WENT WRONG: DURING A ROUTINE CANNULA CHANGE THE NEW CANNULA SPLIT IN TWO PARTS RIGHT AFTER THE INSERTION. THE TUBE SEPARATES FROM THE NECK PLATE. NO BREAKS OR CRACKS OF THE MATERIAL OF TUBE AND NECK PLATE ARE VISIBLE. 2) DESCRIPTION OF HEALTH EFFECT: BLEEDING AT TRACHEOSTOMA PROBABLY CAUSE BY THE TUBE CHANGE.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 21581664 ↗

Device details

UDI-DI	`04035324034116`
Brand	TRACOE twist
Model	REF 303-05
Company	Tracoe medical GmbH
Product code	JOH · Tube tracheostomy and tube cuff
Class	Class 2
FDA submission	K961449
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 29, 2024

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

Shiley 8CN85H
Covidien LP · Tube tracheostomy and tube cuff
1 recall2 deaths354 reports
Shiley 6CN75H
Covidien LP · Tube tracheostomy and tube cuff
1 recall3 deaths240 reports
Shiley 7CN80R
Covidien LP · Tube tracheostomy and tube cuff
2 recalls148 reports
Bivona 67PFSS35
Icu Medical, Inc. · Tube tracheostomy and tube cuff
1 recall166 reports
Bivona 670180
Icu Medical, Inc. · Tube tracheostomy and tube cuff
1 recall140 reports
Bivona 670170
Icu Medical, Inc. · Tube tracheostomy and tube cuff
1 recall10 deaths132 reports
Shiley 6CN75R
Covidien LP · Tube tracheostomy and tube cuff
1 recall1 death121 reports
Bivona 67PFSS40
Icu Medical, Inc. · Tube tracheostomy and tube cuff
1 recall115 reports

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.

How reports and recalls are matched · Editorial policy · Report an error on this page