Portex 101/800/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517076110), received between Jul 26, 2022 and Jul 26, 2022 — classified as 2 malfunctions.

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

• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE RETAINING EYELET FOR FASTENING THE CANNULA RETAINING BAND WAS TORN OPEN. THIS CAUSED THE RETAINING STRAP TO COME LOOSE AND A SECURE HOLD OF THE CANNULA IN THE TRACHEA WAS NO LONGER GUARANTEED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104080 ↗
• MalfunctionJul 26, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE RETAINING EYELET FOR FASTENING THE CANNULA RETAINING BAND WAS TORN OPEN. THIS CAUSED THE RETAINING STRAP TO COME LOOSE AND A SECURE HOLD OF THE CANNULA IN THE TRACHEA WAS NO LONGER GUARANTEED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104000 ↗