Portex 100/136/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019315021459), received between Sep 2, 2025 and Sep 2, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unintended Deflation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT A LEAK TEST OF THE ETT WAS CARRIED OUT BEFORE START OF ANAESTHETIC. DURING INTUBATION WITH A SIZE 8 RAE TUBE, THE CUFF WAS INFLATED, BUT THE BALLOON BEGAN TO DEFLATE SPONTANEOUSLY. FAULTY TUBE WAS REMOVED AND REPLACED IT WITH A NEW SIZE 8 RAE TUBE, SAME LOT NUMBER. POST INTUBATION, A TEST WAS CARRIED OUT ON THE DEFECTIVE RAE TUBE BY INFLATING THE CUFF WHILE THE BALLOON WAS SUBMERGED IN WATER, REVEALED BUBBLES ESCAPING FROM TIP OF THE TUBE BUT NOT AROUND THE BALLOON. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22935122 ↗