Portex 100/179/080Recalls & reported problems
Icu Medical, Inc. · Class 1
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019315022142), received between Mar 26, 2018 and Sep 24, 2026 — classified as 1 injury, 7 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (6 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.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak6
- Deflation Problem2
- Leak/Splash2
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Gas/Air Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50889519 ↗MalfunctionDec 23, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT APPROXIMATELY TWO HOURS AFTER INTUBATION, LEAKAGE WAS OBSERVED FROM THE CUFF, AND THE DEVICE WAS SUBSEQUENTLY REPLACED. THE EVENT INVOLVED A PATIENT, BUT NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23878340 ↗MalfunctionDec 3, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT LEAKAGE FROM THE CUFF WAS OBSERVED SEVERAL TIMES APPROXIMATELY 2 HOURS AFTER INTUBATION. THE TUBE IN THE PATIENT WAS CHANGED AS A RESULT OF THE LEAKAGE. THE SAME HEALTH CARE PROFESSIONALS DID ALL THE PROCEDURES, AND THE INFLATION OF THE CUFF WAS DONE AS ALWAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704924 ↗MalfunctionDec 3, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT LEAKAGE FROM THE CUFF WAS OBSERVED SEVERAL TIMES APPROXIMATELY 2 HOURS AFTER INTUBATION. THE TUBE IN THE PATIENT WAS CHANGED AS A RESULT OF THE LEAKAGE. THE SAME HEALTH CARE PROFESSIONALS DID ALL THE PROCEDURES, AND THE INFLATION OF THE CUFF WAS DONE AS ALWAYS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23704892 ↗MalfunctionNov 24, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE'S PROBE AND THE BALLOON GAUGE WERE CHECKED FOR RE-INFLATION. IN THE MORNING, THERE WAS DOUBT ABOUT THE DEFLATION, SEVERAL MANOMETERS WERE USED FOR TESTING, ALL SHOWING THE SAME RESULT OF DEFLATION. DECISION OF THE ANESTHETIST DOCTOR WAS TO RE-INTUBATE THE PATIENT. DURING VISUAL INSPECTION, SMALL AIR BUBBLES WERE SEEN. AFTER CLEANING OF THE DEVICE IN A BATH AND INFLATING THE BALLOON, AIR BUBBLES WERE AGAIN OBSERVED AT THE JUNCTION BETWEEN THE TUBE AND THE BALLOON, CONFIRMING A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633987 ↗MalfunctionNov 24, 2025Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE'S PROBE AND THE BALLOON GAUGE WERE CHECKED FOR RE-INFLATION. IN THE MORNING, THERE WAS DOUBT ABOUT THE DEFLATION, SEVERAL MANOMETERS WERE USED FOR TESTING, ALL SHOWING THE SAME RESULT OF DEFLATION. DECISION OF THE ANESTHETIST DOCTOR WAS TO RE-INTUBATE THE PATIENT. DURING VISUAL INSPECTION, SMALL AIR BUBBLES WERE SEEN. AFTER CLEANING OF THE DEVICE IN A BATH AND INFLATING THE BALLOON, AIR BUBBLES WERE AGAIN OBSERVED AT THE JUNCTION BETWEEN THE TUBE AND THE BALLOON, CONFIRMING A LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23633839 ↗InjuryMar 26, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SMITHS MEDICAL DEVICE HAD OBSERVED LEAKING BETWEEN THE TUBE AND THE CUFF. THIS ISSUE WAS OBSERVED AFTER 45 MINUTES OF USE. A TUBE CHANGE WAS REQUIRED TO RESOLVE THE ISSUE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7371440 ↗MalfunctionMar 26, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE SMITHS MEDICAL DEVICE HAD OBSERVED LEAKING BETWEEN THE TUBE AND THE CUFF. THIS ISSUE WAS OBSERVED AFTER 24 HOURS OF USE. A TUBE CHANGE WAS REQUIRED TO RESOLVE THE ISSUE. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7371437 ↗
Other IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS devices
- Portex 100/189/090Icu Medical, Inc. · IMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.