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Portex 502060Recalls & reported problems

Icu Medical, Inc. · Class 2

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688037176), received between Jul 14, 2017 and Jul 14, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Crack” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Crack4

Patient problems

  • Discomfort4

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 14, 2017Crack; Crack

    IT WAS REPORTED THAT PORTEX® UNCUFFED D.I.C.® TRACHEOSTOMY TUBE WAS CRACKED. THE FAULT WAS NOTICED AFTER THE PATIENT "FELT DIFFERENT, IRRITATED" AND WOKE UP SEVERAL TIMES AT NIGHT. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR JUST UNDER FOUR WEEKS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Discomfort

    MAUDE report 6714725 ↗
  • MalfunctionJul 14, 2017Crack; Crack

    IT WAS REPORTED THAT PORTEX UNCUFFED D.I.C. TRACHEOSTOMY TUBE WAS CRACKED. THE FAULT WAS NOTICED AFTER THE PATIENT "FELT DIFFERENT, IRRITATED" AND WOKE UP SEVERAL TIMES AT NIGHT. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR JUST UNDER FOUR WEEKS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Discomfort

    MAUDE report 6714719 ↗
  • MalfunctionJul 14, 2017Crack; Crack

    IT WAS REPORTED THAT PORTEX UNCUFFED D.I.C. TRACHEOSTOMY TUBE WAS CRACKED. THE FAULT WAS NOTICED AFTER THE PATIENT "FELT DIFFERENT, IRRITATED" AND WOKE UP SEVERAL TIMES AT NIGHT. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR JUST UNDER FOUR WEEKS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Discomfort

    MAUDE report 6714704 ↗
  • MalfunctionJul 14, 2017Crack; Crack

    IT WAS REPORTED THAT PORTEX UNCUFFED D.I.C. TRACHEOSTOMY TUBE WAS CRACKED. THE FAULT WAS NOTICED AFTER THE PATIENT "FELT DIFFERENT, IRRITATED" AND WOKE UP SEVERAL TIMES AT NIGHT. THE TRACHEOSTOMY TUBE HAD BEEN IN USE FOR JUST UNDER FOUR WEEKS. NO PATIENT INJURY WAS REPORTED.

    Patient problems: Discomfort

    MAUDE report 6714701 ↗

Other Tube, tracheostomy (w/wo connector) devices

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

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.