Portex 101/812/075CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517076431), received between Jan 11, 2024 and Oct 23, 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.

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

  IT WAS REPORTED THAT THE CUFF LEAKS DESPITE BEING FILLED. SEVERAL CASES OCCURRED IN THE RECENT PAST. THERE WAS NO REPORTED PATIENT INVOLVED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372997 ↗
• MalfunctionJun 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS DISCOMFORT WHEN RECONNECTING VENTILATOR AS THERE WAS A LEAK DESPITE WELL-INFLATED BALLOON AND WELL-CLEANED NON-WINDOWED INNER LINING: LOSS OF VOLUME ON VENTILATOR, LEAK NOISE AND ABILITY TO SPEAK. CHANGE OF INNER LINER: IMPROVEMENT FOR 2 MIN, THEN THERE WAS A RECURRENCE. THERE WAS PATIENT INVOLVEMENT AND NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629634 ↗
• MalfunctionJan 11, 2024Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS NO TRACHEOSTOMY TUBE INSIDE THE BOX. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499208 ↗