Portex 450954-NLRecalls & reported problems

All models of Portex (409)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 13
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15019315075865), received between Mar 25, 2025 and Jul 11, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (13 reports).

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 Leak13
Crack1
Material Puncture/Hole1

Patient problems

No Clinical Signs, Symptoms or Conditions13

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484888 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484725 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484631 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484608 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484582 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484559 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484542 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484531 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484518 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484394 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484382 ↗
MalfunctionJul 11, 2025Gas/Air Leak; Gas/Air Leak
IT WAS STATED THAT THE DEVICES WERE HAVING LEAK ISSUES. THEY WENT THROUGH 6 LAST WEEK AND HAD 6 ADDITIONAL CIRCUITS THIS WEEK. THERE WAS NO REPORTED PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22484379 ↗
MalfunctionMar 25, 2025Crack; Material Puncture/Hole; Gas/Air Leak; Crack; Material Puncture/Hole; Gas/Air Leak
IT WAS REPORTED THAT THEY HAD ISSUES WITH CRACKED OR HOLES IN THE CIRCUITS AND FAILED LEAK TEST DUE TO THESE CIRCUITS. IT APPEARED TO LOSE AIR DUE TO HOLES. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21691593 ↗

Device details

UDI-DI	`15019315075865`
Brand	Portex
Model	450954-NL
Company	Icu Medical, Inc.
Product code	CAH · Filter, bacterial, breathing-circuit
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Apr 17, 2025

Device type (GMDN): Anaesthesia breathing circuit, single-use

An assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

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All Filter, bacterial, breathing-circuit 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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