Portex 101/561/080Recalls & 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: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517103373), received between Dec 15, 2023 and Dec 15, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1
Obstruction of Flow1

Patient problems

Forced Expiratory Volume Decreased1
Low Oxygen Saturation1

Recent adverse event reports

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

InjuryDec 15, 2023Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation
IT WAS REPORTED THAT THERE WAS NO VISIBLE DEFORMATION OF THE CUFF BEFORE THE PROCEDURE. AFTER INSERTION OF THE TRACHEOSTOMY TUBE, OXYGEN SATURATION DROPPED. THERE WAS HIGH VENTILATION PRESSURE, NO VOLUME ENTERS THE PATIENT. DURING RE-BRONCHOSCOPY, THE CANNULA OPENING WAS DISPLACED BY THE CUFF (CUFF HERNIA). THIS LEAD TO AN IMMEDIATE CANNULA CHANGE. AFTER THE CANNULA HAS BEEN REMOVED, THERE WAS LATERAL BULGING OF THE CUFF FOUND. THERE WAS PATIENT INVOLVEMENT, MEDICAL INTERVENTION REQUIRED. ADDITIONAL ADVERSE EFFECTS TO THE PATIENT HAVE NOT BEEN REPORTED.
Patient problems: Forced Expiratory Volume Decreased; Low Oxygen Saturation
MAUDE report 18335350 ↗

Device details

UDI-DI	`15019517103373`
Brand	Portex
Model	101/561/080
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
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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