Portex 100/890/090CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315107184), received between May 9, 2018 and May 31, 2018 — classified as 2 malfunctions.

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

• MalfunctionMay 31, 2018Fracture; Fracture

  IT WAS REPORTED THAT FISSURES WERE OBSERVED ON THE INNER CANNULA OF A TRACHEOSTOMY TUBE AT THE MOMENT OF CLEANING. THE INNER CANNULA HAD BEEN SPLIT ALONG THE ENTIRE OUTER CURVE. CUSTOMER HAD TO CHANGE THE INNER CANNULA. NO PATIENT DETAILS WERE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7558058 ↗
• MalfunctionMay 9, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® ULTRAPERC® SINGLE STAGE DILATOR WAS FOUND TO BE PROTRUDING 5MM FROM THE END OF THE UNIPERC TRACHEOSTOMY (TRACH) TUBE CAUSING COUGHING AND DISCOMFORT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Code Available; Pain

  MAUDE report 7500867 ↗