Portex 100/110/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 15019315050794), received between Jun 18, 2020 and Dec 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Gas/Air Leak; Material Split, Cut or Torn; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS A PIERCED WIRE TUBE. IT WAS OBSERVED BY THE ANESTHESIOLOGIST THAT THE WIRE TUBE PRESENTED LEAK AFTER INTUBATION. IT WAS REMOVED AND A NEW ONE WAS USED. THERE WAS PATIENT INVOLVEMENT AND HARM REPORTED, WHICH WAS THAT THE PATIENT HAD DECREASED OXYGEN SATURATION.

  Patient problems: Low Oxygen Saturation

  MAUDE report 23852375 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING INTUBATION, THE CUFF WAS OBSERVED TO HAVE HOLES. PATIENT HARM WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17302543 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING THE OROTRACHEAL INTUBATION PROCEDURE, CANNULA WAS REQUESTED AND OBSERVED THAT CUFF HAD HOLES. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17302471 ↗
• MalfunctionApr 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE HAS A LEAK AND THE BALLOON SLOWLY DEFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16831375 ↗
• MalfunctionSep 9, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WAS DAMAGED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15393726 ↗
• MalfunctionJun 18, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE DID NOT INFLATE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171482 ↗