Portex 100/110/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315050787), received between Apr 17, 2019 and Jan 28, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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.

• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT PRESENTED A CRACK, WAS BROKEN, OR HAD A BROKEN PART, AND THE NO. 7 WIRE CANNULA SHOWED SIGNS OF LEAKAGE DUE TO A PUNCTURED CUFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200630 ↗
• MalfunctionNov 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT HAD A LEAKAGE, THE CUFF WAS PUNCTURED. THERE WAS NO REPORTED PATIENT INVOLVEMENT OR HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23544991 ↗
• MalfunctionApr 17, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CUFF A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS UNABLE TO BE INFLATED DURING A PRE USE CHECK.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8524075 ↗