Portex 101/800/080Recalls & reported problems

All models of Portex (409)

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 15019517076936), received between Mar 16, 2026 and Mar 16, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 Puncture/Hole1

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.

MalfunctionMar 16, 2026Material Puncture/Hole
IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, WHEN THE CANNULA WAS OPENED, IT WAS FOUND TO HAVE A HOLE, WHICH WAS ONLY NOTICED AFTER THE PORTEX 8.0 TRACHEAL TUBE WAS PLACED AND VENTILATING. THE SURGEON NOTICED THAT THE CANNULA HAD A PUNCTURED CUFF AND IT WAS REPLACED. THERE WAS NO REPORTED HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24611546 ↗

Device details

UDI-DI	`15019517076936`
Brand	Portex
Model	101/800/080
Company	Icu Medical, Inc.
Product code	BTO · Tube, tracheostomy (w/wo connector)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Jun 9, 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 (w/wo connector) devices

Portex 101/860/080CZ
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
188 reports
Portex 101/860/075CZ
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
115 reports
Bivona 60SP040
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall20 reports
Bivona 60SP050
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall13 reports
Bivona 60P040
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall12 reports
Portex 101/860/070CZ
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
60 reports
Bivona 60SP045
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall8 reports
Portex 101/870/080CZ
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
55 reports

All Tube, tracheostomy (w/wo connector) 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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