Portex 100/120/300Recalls & 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
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315055904), received between Mar 18, 2024 and Mar 18, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Failure to Disconnect” (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.
Reports received per month
Most reported problems
Device problems
- Failure to Disconnect1
Patient problems
- Airway Obstruction1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathMar 18, 2024Failure to Disconnect; Failure to Disconnect
THE INITIAL REPORTER MR. (B)(6)., FROM (B)(6) STATED THAT THEY HAD A LIFE-THREATENING SITUATION FOR A PATIENT. WHEN STARTING THE INTUBATION PROCESS (NOTED TO BE A "DIFFICULT INTUBATION"), THE DEVICE BECAME OCCUPIED AND STUCK WITHOUT THE POSSIBILITY OF REMOVING IT FROM THE TUBE. IT WAS STATED THAT MEDICAL INTERVENTION WAS NECESSARY. IT WAS NOT POSSIBLE TO PROVIDE MORE INFORMATION REGARDING THE SPECIFIC MEDICAL INTERVENTION THAT OCCURRED. THE CUSTOMER ALSO INFORMED THAT IT IS NOT POSSIBLE TO PROVIDE INFORMATION REGARDING WHERE THE DEATH OCCURRED, WHAT WAS THE STATUS OF THE PATIENT AND THEY DID NOT PROVIDE PATIENT¿S DETAILS. ONLY ONE SAMPLE OF THIS AFFECTED BATCH LOT WAS USED IN THIS EVENT. TWO PRODUCTS IN TOTAL WERE INVOLVED. THE HOSPITAL DOES NOT WANT TO PROVIDE THE INFORMATION ABOUT WHAT KIND OF TRACHEAL TUBE WAS USED. ACCORDING TO THE HEAD NURSE OF THE WARD, (B)(6), THE PERSON WHO PERFORMED THE INTUBATION WAS AN ANESTHETIST. HE DID NOT PROVIDE FURTHER INFORMATION ABOUT THE ANESTHETIST. IT IS UNKNOWN IF IT WAS THE FIRST TIME SHE PERFORMED AN INTUBATION. (B)(6) COMMENTED THAT IT WAS A DIFFICULT INTUBATION DURING AN EMERGENCY WITH AN OBESE PATIENT. THEY DID NOT USE ANY LUBRICANT DUE
Patient problems: Airway Obstruction
MAUDE report 18926217 ↗
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- Shiley 85865Covidien LP · STYLET, TRACHEAL TUBE3 reports
- Vital Signs™ S5000NAirlife · STYLET, TRACHEAL TUBE2 reports
- Mallinckrodt 85864Covidien LP · STYLET, TRACHEAL TUBE2 reports
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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