Portex 100/899/070CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315107221), received between Mar 16, 2020 and Aug 1, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A TRACHEOSTOMY PUT IN PLACE APPROXIMATELY OVER THREE (3) AND A HALF WEEKS AGO COUNTING FROM (B)(6) 2025. DUE TO THE CLIP FAILING A NEW ONE WAS PUT IN PLACE. THE CLIP HELD IN PLACE WITH NO ISSUES FOR A WEEK AND A HALF BUT THEN STARTED TO SLIP CAUSING THE TRACHEOSTOMY TO COME OUT OF PLACE. THE REPORTER STATED THEY NEEDED TO CHANGE THE TUBE AND INSERT A NEW ONE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE HARM REPORTED. THE SECOND EVENT IS DOCUMENTED ON EMDR-72501

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686608 ↗
• MalfunctionAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT HAD A TRACHEOSTOMY PUT IN PLACE APPROXIMATELY OVER THREE (3) AND A HALF WEEKS AGO COUNTING FROM (B)(6) 2025. DUE TO THE CLIP FAILING A NEW ONE WAS PUT IN PLACE. THE CLIP HELD IN PLACE WITH NO ISSUES FOR A WEEK AND A HALF BUT THEN STARTED TO SLIP CAUSING THE TRACHEOSTOMY TO COME OUT OF PLACE. THE REPORTER STATED THEY NEEDED TO CHANGE THE TUBE AND INSERT A NEW ONE. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE HARM REPORTED. THE SECOND EVENT IS DOCUMENTED ON EMDR-73306.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686514 ↗
• MalfunctionMar 16, 2020Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BLUE LOCKSYSTEM ON A SMITHS MEDICAL REGARDING A PORTEX UNIPERC INNER CANNULA DID NOT WORK. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9833561 ↗