Portex 100/890/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315107160), received between Jan 13, 2023 and Jan 13, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Deformation” (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.

• InjuryJan 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WITH ADJUSTABLE FLANGE TRACHEOSTOMY TUBE HAD 2 INNER CANNULAS FOR USE. THE CORRECT SWABS WERE USED FOR CLEANING BUT IT WAS NOTED THAT THE INNER LINERS HAD BECOME MIS-SHAPE DURING USE AND THE INNER COATING APPEARED TO BE WORN AWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164208 ↗
• InjuryJan 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PATIENT WITH ADJUSTABLE FLANGE TRACHEOSTOMY TUBE HAD 2 INNER CANNULAS FOR USE. THE CORRECT SWABS WERE USED FOR CLEANING BUT IT WAS NOTED THAT THE INNER LINERS HAD BECOME MIS-SHAPE DURING USE AND THE INNER COATING APPEARED TO BE WORN AWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16162751 ↗