Portex 101/800/060CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517076066), received between Jul 22, 2021 and Jul 9, 2025 — classified as 2 malfunctions.

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

• MalfunctionJul 9, 2025Break; Break

  IT WAS REPORTED THAT THE PATIENT DID NOT PULL THE TUBE WHO WAS OBSERVED 24 HOURS A DAY. THE TUBE WAS INSERTED ONE DAY PRIOR TO BREAKAGE. THE PATIENT WAS ON OVERNIGHT VENTILATION. THERE WAS A MEDICAL INTERVENTION REQUIRED, AND EMERGENCY TUBE WAS CHANGED. THE EVENT WAS RESOLVED, AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22464823 ↗
• MalfunctionJul 22, 2021Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT MALFUNCTIONED. THE CUSTOMER STARTED USING THE PRODUCT FROM REGULAR REPLACEMENT AND IT WORKED FOR A WHILE. HOWEVER, AFTER THAT, THE PATIENT'S MOTHER NOTICED THE INFLATION LINE FOR THE PILOT BALLOON WAS TORN. SO THE CUSTOMER CHANGED THE PRODUCT ANOTHER NEW ONE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215196 ↗