Portex 101/815/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517077346), received between Mar 27, 2023 and Jan 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Incomplete or Missing Packaging” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Disconnection; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE TRACH WAS DISLODGED, ON PATIENT NECK WITH TRACH TIES STILL ATTACHED. NO BLEEDING WAS NOTED AROUND STOMA SITE. THE WRITER WAS ABLE TO PASS A SUCTION CATHETER THROUGH THE STOMA, SO THEY ATTEMPTED TO INSERT THE SAME SIZE 8 PORTEX TRACHEOSTOMY TUBE WITH AN OBTURATOR, BUT THE STOMA WAS TOO TIGHT, AND THE ATTEMPT WAS UNSUCCESSFUL. THE WRITER WAS UNABLE TO FIND A SIZE 7 PORTEX TRACHEOSTOMY TUBE, WHICH WAS THE SAME TYPE BUT SMALLER. THE WRITER WAS LATER ABLE TO FIND AND PLACE A SIZE 7 TRACHEOSTOMY TUBE ON THE FIRST ATTEMPT. THE PATIENT THEN BECAME TACHYPNEIC BUT WAS NOT IN DISTRESS. THE SPO2 WAS 94 PERCENT ON OPTIFLOW AT 85 PERCENT AND 50 L. THE RN PLACED RESTRAINTS ON THE PATIENT. THERE WERE PATIENT INJURY AND NO PATIENT DEATH.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24042523 ↗
• MalfunctionJun 2, 2023Sharp Edges; Sharp Edges

  IT WAS REPORTED THAT THE LENGTH OF THE INNER CANNULA EXCEEDED THE LENGTH OF THE TRACH LEAVING A SHARP EDGE TO COME IN CONTACT WITH THE PATIENTS TRACHEA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049220 ↗
• MalfunctionApr 4, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT WHEN A CUSTOMER OPENED A TRACH PACKAGING IT WAS NOTICED THAT THE PARTS OF THE INNER CONTENTS WERE MISSING. THESE WERE SEALED BOXES. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16676304 ↗
• MalfunctionMar 27, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING THE USE OF A TRACH, IT WAS DISCOVERED THAT THE TRACH WAS MISSING FROM THE UNOPENED OUTSIDE BOX, AND ONLY INSTRUCTIONS WERE FOUND INSIDE. THE DOCTOR SEARCHED FOR ANOTHER TRACH ON THE SHELF, BUT FOUND THE SAME SITUATION. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16622298 ↗
• MalfunctionMar 27, 2023Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT DURING THE USE OF A TRACH, IT WAS DISCOVERED THAT THE TRACH WAS MISSING FROM THE UNOPENED OUTSIDE BOX, AND ONLY INSTRUCTIONS WERE FOUND INSIDE. THE DOCTOR SEARCHED FOR ANOTHER TRACH ON THE SHELF, BUT FOUND THE SAME SITUATION. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16622244 ↗