Portex 101/810/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077001), received between Oct 21, 2025 and May 8, 2026 — 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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING PATIENT MOBILIZATION, A LEAKING NOISE WAS OBSERVED, REQUIRING REPEATED REINFLATION OF THE BALLOON. CONSEQUENCES OF THE INCIDENT: A REPLACEMENT DEVICE WAS USED. ONGOING MONITORING OF DELIVERED TIDAL VOLUMES AND POTENTIAL LEAKS WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129429 ↗
• MalfunctionOct 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED AFTER USAGE. THE TRACHEOSTOMY TUBE NO. 7.5 WAS FOUND TO BE DEFECTIVE DUE TO LEAKAGE IN THE BALLOON SECTION. THE TUBE WAS REPLACED WITH A TRACHEOSTOMY TUBE NO. 7, WHICH WAS FUNCTIONING PROPERLY. THE PATIENT REMAINED STABLE AFTER THE REPLACEMENT PROCEDURE. THE EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THE ISSUE WAS RESOLVED BY CHANGING TO A NEW PRODUCT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353915 ↗