Portex 536080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688051943), received between Mar 6, 2018 and Mar 6, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjuryMar 6, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® PER-FIT¿ TRACHEOSTOMY TUBE WOULD NOT RETAIN AIR. THE CUFF WAS TESTED BY THE DOCTOR PRIOR TO INSERTION; BUT ONCE INSERTED, THE BALLOON ON THE CUFF WOULD NOT HOLD AIR. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317136 ↗
• InjuryMar 6, 2018Fracture; Fracture

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® PER-FIT¿ TRACHEOSTOMY TUBE WOULD NOT RETAIN AIR. THE CUFF WAS TESTED BY THE DOCTOR PRIOR TO INSERTION; BUT ONCE INSERTED, THE BALLOON ON THE CUFF WOULD NOT HOLD AIR. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7317133 ↗