Skip to content

Portex 100/111/045Recalls & reported problems

Icu Medical, Inc. · Class 2

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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315018886), received between Apr 28, 2021 and Apr 28, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Connection Problem” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K790312); they may or may not involve this specific model.

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

  • Connection Problem1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • InjuryApr 28, 2021Connection Problem; Connection Problem

    ADDITIONAL INFORMATION: THERE WAS NO ADVERSE OUTCOME AS THE PATIENT WAS SUCCESSFULLY RE-INTUBATED AND FULLY RELEASING THE CLIP.

    Patient problems: Insufficient Information

    MAUDE report 11741696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790312. One submission often covers many models, so check the product and lot details in each record.

  • Z-1289-2025 · Feb 13, 2025 · Open, Classified
    Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025
  • Z-2538-2014 · Jul 7, 2014 · Terminated
    H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
  • Z-2536-2014 · Jul 7, 2014 · Terminated
    4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
  • Z-2537-2014 · Jul 7, 2014 · Terminated
    H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
  • Z-2539-2014 · Jul 7, 2014 · Terminated
    H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
  • Z-1641-2014 · Apr 10, 2014 · Terminated
    Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space con

Other Tube, tracheal (w/wo connector) devices

All Tube, tracheal (w/wo connector) devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page