TRACOE twist plus REF 521-07Recalls & reported problems

Tracoe medical GmbH · Spare Inner Cannulas, with 15 mm Connector, 3 units · 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 04035324018192), received between May 27, 2026 and May 27, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Stenosis” (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

Device Stenosis1

Patient problems

Airway Obstruction1

Recent adverse event reports

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

MalfunctionMay 27, 2026Device Stenosis
WHEN THE HCP DID A REGULAR CHANGE OF THE INNER CANULA, DUE TO A CLEANING ROUTINE, HE GRABBED A NEW INNER CANULA. HE INSERTED IT INTO THE PATIENT. AFTER A WHILE THE PATIENT STARTED COUGHING AND HAD A BIT OF SPUTUM. WHEN THE HCP WANTED TO INSERT A SUCTION TUBE INTO THE CANULA, HE WAS NOT ABLE TO REACH THE SPUTUM DUE TO A PIECE OF PLASTIC INSIDE THE INNER CANULA.
Patient problems: Airway Obstruction
MAUDE report 25300208 ↗

Device details

UDI-DI	`04035324018192`
Brand	TRACOE twist plus
Model	REF 521-07
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.

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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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