Portex 100/189/090Recalls & 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 15019315059568), received between Aug 2, 2022 and Aug 2, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Disconnection” (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.

Most reported problems

Device problems

Disconnection1
Fitting Problem1

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.

MalfunctionAug 2, 2022Disconnection; Fitting Problem; Disconnection; Fitting Problem
IT WAS REPORTED THAT THE BLUE 15MM CONNECTOR KEPT DISCONNECTING FROM THE TRACHEAL TUBE. THE TIP WAS NOT DEEP ENOUGH INSIDE THE TUBE AND JUST DISCONNECTS. NO CLINICAL CONSEQUENCE, ISSUE OCCURRED UPON OPENING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15154286 ↗

Device details

UDI-DI	`15019315059568`
Brand	Portex
Model	100/189/090
Company	Icu Medical, Inc.
Product code	NTR · IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS
Class	Class 1
FDA submission	K081086
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): Cuff-suction endotracheal tube

A hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/lengths for adult and paediatric patients. This is a single-use device.

Other IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS devices

Portex 100/179/080
Icu Medical, Inc. · IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS
8 reports

All IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS 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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