Portex 101/810/085Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077025), received between Aug 6, 2025 and Jan 26, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Unintended Deflation

  IT WAS REPORTED THAT THERE WAS A DEFECTIVE BALLOON, INFLATED MULTIPLE TIMES IN THE LATE MORNING, THEN FOUND TO DEFLATE FLAT AS SOON AS IT IS PRESSED AT 11:30 AND A CANNULA CHANGE WAS MADE. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179196 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT IN THE EAR, NOSE, AND THROAT DEPARTMENT, IT WAS FOUND THAT THE INTERNAL SLEEVE WAS NOT CLIPPED ONTO THE PATIENT¿S TRACHEOSTOMY CANNULA. AN IDENTICAL DEVICE WAS USED AS A REPLACEMENT. NO CLINICAL CONSEQUENCES WERE OBSERVED. THERE WAS PATIENT INVOLVEMENT. THE PATIENT IS IN AMBIENT AIR AND BREATHES INDEPENDENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22728708 ↗