Portex 100/597/080Recalls & reported problems

All models of Portex (409)

Data updated Oct 18, 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 15019315060298), received between Dec 30, 2024 and Dec 30, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Deflation Problem1
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 30, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak
IT WAS REPORTED THAT THE BALLOON CUFF ON THE TRACHEOSTOMY TUBE WAS LEAKING. FREQUENT TOP-UP'S OF AIR REQUIRED TO MAINTAIN SEAL OF CUFF. IT WAS REALIZED THE BALLOON CUFF HAD A FAULTY VALVE. WHEN THE VALVE WAS SECURED WITH A SMART-SITE THERE WAS NO FURTHER DEFLATION OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21037139 ↗

Device details

UDI-DI	`15019315060298`
Brand	Portex
Model	100/597/080
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	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2025

Device type (GMDN): Tracheostomy kit, single-use

A collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. 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
Bivona 60SN040
Icu Medical, Inc. · Tube, tracheostomy (w/wo connector)
1 recall5 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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