Portex 100/199/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315022364), received between Feb 15, 2023 and Feb 2, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THERE WAS REINTUBATION DUE TO PERSISTENT CUFF LEAK AND CONCERN OVER CUFF INTEGRITY, REPEATED INFLATION OF PILOT BALLOON AND SUBSEQUENT LOSS OF PRESSURE. THERE WAS PATIENT INVOLVEMENT. THERE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235655 ↗
• MalfunctionApr 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE IS A CUFF AIR LEAKAGE. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908985 ↗
• MalfunctionFeb 15, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS INFLATING THE CUFF DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM IT WAS OBSERVED. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16381572 ↗