TRACHEOTEC 18920-045Recalls & reported problems

Andreas Fahl Medizintechnik-Vertrieb GmbH · TRACHEOTEC VARIO CUFF, SIZE 4.5 · 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 04051948115277), received between Dec 9, 2024 and Dec 9, 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
Material Split, Cut or Torn1

Patient problems

Unintended Extubation1

Recent adverse event reports

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

MalfunctionDec 9, 2024Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, WHEN THE TUBE WAS PLACED DURING THE ORGAN INCISION SURGERY, IT WAS FOUND THAT THE CUFF WAS DAMAGED AND COULD NOT BE INFLATED. THE TRACHEOTOMY CANNULA WAS REPLACED AND THE TUBE WAS REINSERTED.
Patient problems: Unintended Extubation
MAUDE report 20878556 ↗

Device details

UDI-DI	`04051948115277`
Brand	TRACHEOTEC
Model	18920-045
Company	Andreas Fahl Medizintechnik-Vertrieb GmbH
Product code	JOH · Tube Tracheostomy And Tube Cuff
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	Yes
MRI safety	MR Unsafe
Status	Not in Commercial Distribution
Record updated	Oct 13, 2021

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

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 metal [stainless steel, silver (Ag) and/or silver plated brass] or 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 secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable 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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