Portex 100/815/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315045387), received between Aug 3, 2017 and Feb 12, 2018 — classified as 3 injuries.

The most frequently reported specific device problem is “Inflation Problem” (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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 12, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BLUE LINE ULTRA® CUFFED TRACHEOSTOMY TUBE WOULD NOT INFLATE. THE FAULT WAS OBSERVED DURING INSERTION. THE PATIENT WAS SUCCESSFULLY RE-INTUBATED WITH A NEW DEVICE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263249 ↗
• InjuryFeb 12, 2018Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BLUE LINE ULTRA® CUFFED TRACHEOSTOMY TUBE WOULD NOT INFLATE. THE FAULT WAS OBSERVED DURING INSERTION. THE PATIENT WAS SUCCESSFULLY RE-INTUBATED WITH A NEW DEVICE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7263244 ↗
• InjuryAug 3, 2017Human Factors Issue; Human Factors Issue

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A STAGE 3 PRESSURE SORE AT THE SITE OF A PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE FLANGE ON THE DEVICE DOES NOT CONTAIN ANY GEL LIKE OR OTHER SOFT BARRIER TO HELP PREVENT PRESSURE INJURIES. THE TRACHEOSTOMY TUBE REQUIRES USE OF OTHER MATERIALS SUCH AS GAUZE OR GEL PADS TO DECREASE/ELIMINATE PRESSURE. NO PERMANENT INJURY WAS REPORTED.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 6764961 ↗