TRACOE® twist plus REF 316-08-PRecalls & reported problems

Tracoe medical GmbH · TRACOE twist plus Tracheostomy Tube, Double Fenestrated, with Low Pressure Cuff and Subglottic Suction Line, with atraumatic insertion system · Class 2

All models of TRACOE twist plus (13)

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 04035324019229), received between Dec 2, 2024 and Dec 2, 2024 — classified as 1 malfunction.

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

Gas/Air Leak1

Patient problems

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.

MalfunctionDec 2, 2024Gas/Air Leak; Gas/Air Leak
1) CUFF LEAK WAS OBSERVED DURING USE AFTER 23 DAYS OF USE. 2) NO HEALTH EFFECT TO THE PATIENT OCCURED. THE TRACHEOSTOMY TUBE WITH THE CUFF PROBLEM WAS CHANGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20817955 ↗

Device details

UDI-DI	`04035324019229`
Brand	TRACOE® twist plus
Model	REF 316-08-P
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	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	May 8, 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.

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Bivona 670170
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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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