Portex 100/189/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315059513), received between Mar 18, 2021 and Aug 14, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• MalfunctionAug 14, 2024Difficult to Remove; Material Protrusion/Extrusion; Difficult to Remove; Material Protrusion/Extrusion

  IT WAS REPORTED THAT UPON EXTUBATION, IT WAS FOUND THAT THE ENDOTRACHEAL TUBE (ETT) WAS STUCK ON SOMETHING AND COULD NOT BE PULLED OUT. THIS OCCURRED DURING 6 DIFFERENT EXTUBATIONS THAT WERE KNOWN. FOR 2 OF THESE EXTUBATIONS, A BRONCHOSCOPE WAS USED WHICH CONFIRMED NO SECRETIONS OR ANYTHING ELSE WAS ATTACHED TO THE ETT. EXAMINATION OF THE ETT SHOWED THAT THE DESIGN OF THE TUBE MAY BE THE ISSUE. THE TOP PORTION OF THE CUFF HAD A STIFF PROTRUDING EDGE WHEN DEFLATED AND MAY HAVE GOT CAUGHT ON THE VOCAL CORDS. THE DOCTOR DISCOVERED THE PROBLEM WHEN TRYING TO EXTUBATE THE PATIENT. PATIENT INTUBATED FOR SEVERAL HOURS OVERNIGHT WITH THE PRODUCT IN PLACE. INTUBATION WAS NOT NECESSARY. MEDICAL INTERVENTION WAS REQUIRED AS A BRONCHOSCOPE WAS REQUIRED TO EXTUBATE THE PATIENT DUE TO THE EXCESSIVE FORCE REQUIRED TO REMOVE THE ETT, TO ENSURE NO TRAUMA. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982144 ↗
• InjuryMar 18, 2021Separation Failure; Gas/Air Leak; Separation Failure; Gas/Air Leak

  REPORTED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES SACETT BALLOON WAS TESTED BEFORE THE TUBE WAS INSERTED AND THEN AFTER INSERTING THE TUBE, THE BALLOON DID NOT WORK AND DID NOT INFLATE. ALSO REPORTED, IN ADDITION THE CUFF PILOT TUBE IS NOT INSTALLED WELL AND WHEN USING IT COMES OUT BY ITSELF. THIS WAS REPORTED TO OCCUR ON SEVEN OCCASIONS AS INCIDENTS DESCRIBED.

  Patient problems: Insufficient Information

  MAUDE report 11517517 ↗