Portex 100/870/085CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019315104879), received between Apr 5, 2021 and Oct 1, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 1, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUFF TORE DURING THE PASSAGE THROUGH THE PATIENT'S TRACHEA, THE CANNULA WAS TESTED, CONFIRMING THAT THE CUFF WAS NOT INFLATING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344943 ↗
• MalfunctionJun 19, 2024Crack; Crack

  IT WAS REPORTED THAT CRACKS WERE FOUND IN THE INNER CANNULA PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19566580 ↗
• MalfunctionSep 13, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE PATIENT IN POSITION TO PERFORM A TRACHEOSTOMY WHEN OPENING THE TRACHEOSTOMY BOX, IT WAS EMPTY WITHOUT THE CANNULA INSIDE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410417 ↗
• MalfunctionJul 5, 2022Fluid/Blood Leak; Material Puncture/Hole; Gas/Air Leak; Fluid/Blood Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT ONE UNIT OF PORTEX 100/870/085 CANNULA UNIT WAS PRESENTING DEFECTIVE. THE BALLOON WAS EMPTYING. A VIDEO OF THE REPORTED PROBLEM WAS RECEIVED, HOWEVER NO INFORMATION WAS PROVIDED AS TO WHEN THE ISSUE WAS FOUND. THE VIDEO SHOWS THE TRACH TUBE IN A PLASTIC CUP OF WATER/SOLUTION, WITH THE CUFF ATTEMPTING TO BE FILLED, HOWEVER AIR BUBBLES CONTINUE TO COME OUT OF THE BALLOON, AND IT DOES NOT FILL UP. NO PATIENT INJURY OR INVOLVEMENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14915829 ↗
• MalfunctionJun 27, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR FOUND THE CUFF LEAKED DURING TESTING PROCESS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831198 ↗
• InjuryApr 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE TUBE CUFF HAD BEEN LEAKING AND NOT HOLDING PRESSURE. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14043570 ↗
• MalfunctionApr 7, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF LEAK, ON REMOVAL FLUID IN CUFF, PATIENT REQUIRED EARLIER CHANGE DATE. HCP FOUND A LARGE HOLE IN CUFF. NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14040902 ↗
• MalfunctionApr 5, 2021Gas/Air Leak; Gas/Air Leak

  SME SIGNED OFF ON REPORT. NO PRODUCT WAS RETURNED., SUMMARY OF ENGINEERING PRACTICE IN H 10.

  Patient problems: Insufficient Information

  MAUDE report 11616441 ↗