Skip to content

Portex 100/541/080Recalls & reported problems

Icu Medical, Inc. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315028793), received between Sep 6, 2018 and Jan 7, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Dull, Blunt” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Dull, Blunt1
  • Failure to Advance1
  • Fracture1
  • Positioning Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 7, 2022Fracture; Dull, Blunt; Fracture; Dull, Blunt

    IT WAS REPORTED THAT THE PERCUTANEOUS TRACHEOSTOMY TUBE WAS DIFFICULT TO PUNCTURE. THE TIP OF THE PLASTIC NEEDLE SHEATH WAS FOUND BROKEN. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13197065 ↗
  • MalfunctionSep 6, 2018Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

    IT WAS REPORTED THAT THE GUIDE WIRE DID NOT PASS THROUGH THE NEEDLE AND INTO THE TRACHEOSTOMY CANNULA.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7852532 ↗

Other Tube, tracheostomy (w/wo connector) devices

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

Sources and updates

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