Portex 100/503/200Recalls & reported problems
Icu Medical, Inc. · Class 1
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315031823), received between Aug 8, 2019 and Apr 7, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Disconnection1
- Stretched1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Consequences Or Impact To Patient1
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2025Disconnection; Stretched; Disconnection; Stretched
IT WAS REPORTED THAT THE VELCRO ON THE TUBE HOLDER COMES OFF, AND THE RUBBER PART STRETCHES. THIS CAUSES THE TRACHEOTOMY TUBE TO COME OUT. AMONG 37 TRACHEOSTOMY PATIENTS, 20 USED VENTILATORS. TUBE HOLDERS WERE CHANGED WEEKLY, WITH GAUZE PLACED BETWEEN THE TUBE AND NECK. MANY PATIENTS HAD HEAVY SECRETIONS. IN ONE CASE, THE TRACHEOSTOMY TUBE CAME OUT DUE TO THE RUBBER PART STRETCHING, AND IN ANOTHER, THE TUBE HOLDER BECAME WET, CAUSING THE VELCRO TO COME OFF. THIS OCCURRED DURING PATIENT USE, DURING INFUSION. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21786658 ↗InjuryOct 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION WAS RECEIVED THAT THE PATIENT DECANNULATED FOLLOWING A COUGH WHILE A SMITHS MEDICAL ENDOTRACHEAL TUBE SECUREMENT DEVICE WAS IN USE. NO ADVERSE EFFECTS REPORTED.
Patient problems: No Information
MAUDE report 9168549 ↗MalfunctionAug 8, 2019Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE HOLDER DETACHED SUCH THAT THERE WAS A RISK OF THE TRACHEOSTOMY TUBE BEING REMOVED. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8876323 ↗
Other SUPPORT, BREATHING TUBE devices
- NEO-fit 42-2540Coopersurgical, Inc. · Support, Breathing Tube1 recall9 reports
- Universal Bite Block, Adult 11160B&B Medical Technologies · Support, Breathing Tube1 report
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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