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Portex 101/816/070Recalls & 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
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 15019517077414), received between May 26, 2023 and Jun 2, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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

  • Device Appears to Trigger Rejection1
  • Sharp Edges1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • Skin Inflammation/ Irritation1
  • Sore Throat1
  • Stomatitis1

Recent adverse event reports

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

  • MalfunctionJun 2, 2023Sharp Edges; Sharp Edges

    IT WAS REPORTED THAT THE LENGTH OF THE INNER CANNULA EXCEEDED THE LENGTH OF THE TRACH LEAVING A SHARP EDGE TO COME IN CONTACT WITH THE PATIENTS TRACHEA. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17049353 ↗
  • MalfunctionMay 26, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

    IT WAS REPORTED THAT AFTER HAVING USED A DIFFERENT MODEL OF TRACH FOR SEVERAL YEARS, THE PATIENT'S TRACH WAS CHANGED TO A PORTEX BLUSELECT TRACHEOSTOMY TUBE. AFTER CHANGING TO THE NEW TRACH, THE PATIENT WAS EXPERIENCING PROBLEMS WHICH CONSISTED OF A BLOODY AND SWOLLEN STOMA. THE ENT "SCOPED" THE PATIENT AND OBSERVED A BLOODY AREA ON ONE SIDE OF THE NEW TRACH AND GRANULATION ON THE OTHER. THE FOLLOWING WEEK THE ENT AGAIN "SCOPED" THE PATIENT AND NOTED THE REPORTED ISSUES HAD GOTTEN WORSE WHICH RESULTED IN REMOVING THE NEW TRACH AND REPLACING WITH THE PREVIOUS MODEL THE PATIENT'S PARENT HAD WITH THEM. THE CUSTOMER NOTED THAT THE INSTRUCTION FOR USE STATES "THAT IF A PATIENT HAS BEEN ON A PARTICULAR TRACH FOR MANY YEARS, THEY COULD EXPERIENCE PROBLEMS WITH ACCEPTING THIS TRACH".

    Patient problems: Skin Inflammation/ Irritation; Sore Throat; Stomatitis

    MAUDE report 17010083 ↗

Other Tube, tracheostomy (w/wo connector) devices

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

Sources and updates

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