Portex 101/810/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077018), received between Apr 23, 2025 and Apr 23, 2025 — classified as 2 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WERE ISSUES WITH TWO CANNULAS. THE FIRST WAS CHANGED AND ITS CUFF LOST AIR DURING THE NIGHT, REQUIRING REPLACEMENT THE NEXT DAY. THE PATIENT CONTINUED TREATMENT WITHOUT ISSUE FOR FOUR DAYS BEFORE THE SECOND CANNULA ALSO EXPERIENCED AIR LEAKAGE, REQUIRING ANOTHER REPLACEMENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21895476 ↗
• MalfunctionApr 23, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WERE ISSUES WITH TWO CANNULAS. THE FIRST WAS CHANGED AND ITS CUFF LOST AIR DURING THE NIGHT, REQUIRING REPLACEMENT THE NEXT DAY. THE PATIENT CONTINUED TREATMENT WITHOUT ISSUE FOR FOUR DAYS BEFORE THE SECOND CANNULA ALSO EXPERIENCED AIR LEAKAGE, REQUIRING ANOTHER REPLACEMENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21894516 ↗