Portex 100/136/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315021305), received between Sep 6, 2022 and Sep 11, 2025 — 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 18, 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.

• MalfunctionSep 11, 2025Leak/Splash; Material Puncture/Hole; Gas/Air Leak; Leak/Splash; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS NO PROBLEM DURING THE PRE-USE CHECK, BUT AFTER ANESTHESIA INTRODUCTION AND INTUBATION, A LEAK WAS CONFIRMED. THERE WAS PATIENT INVOLVED/NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23025268 ↗
• MalfunctionDec 7, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS CHECKED FOR LEAKS DURING PRE-USE CHECKS. A CUFF LEAK WAS DETECTED. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18283989 ↗
• MalfunctionSep 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND DIFFICULTY IN INFLATING THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362507 ↗