Portex 100/136/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019315021329), received between Jul 20, 2020 and Dec 8, 2025 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF IS NOT INFLATING. IT APPEARS THAT THE INSIDE OF THE PILOT BALLOON IS STICKING TOGETHER. THIS OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744344 ↗
• MalfunctionJul 22, 2025Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT POST-PROCEDURE, THE BALLOON WAS DEFLATED FOR REMOVAL BUT IT REMAINED INFLATED. PHOTOS ARE ENCLOSED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568173 ↗
• MalfunctionApr 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE CUFF. THIS OCCURRED DURING PRIMING, AND THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21745110 ↗
• MalfunctionMay 3, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKS FROM THE INFLATION LINE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19242852 ↗
• MalfunctionDec 7, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT UPON OPENING THERE WAS "DIRT" NEAR THE LABEL. THERE WAS A "BROWN LIQUID-LIKE" STAIN NEAR THE LABEL. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18287858 ↗
• MalfunctionApr 6, 2023Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER FOUND DIFFICULTY INFLATING AND DEFLATING THE CUFF. NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16693172 ↗
• MalfunctionJul 21, 2020Leak/Splash; Leak/Splash

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES POLAR MALFUNCTIONED. NO ANOMALY IN THE PRODUCT WAS OBSERVED AT A PRE-USE CHECK. HOWEVER, AFTER INTUBATING IT INTO THE PATIENT USING AN AIRWAY SCOPE, WHEN THE CUSTOMER ATTEMPTED TO PUT AIR INTO IT, HE NOTICED THE CUFF DID NOT INFLATE. ALSO, HE HEARD A SOUND OF AIR LEAKAGE FROM THE PILOT BALLOON. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10302613 ↗
• MalfunctionJul 20, 2020Leak/Splash; Leak/Splash

  INFORMATION RECEIVED A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES POLAR MALFUNCTIONED. NO ANOMALY IN THE PRODUCT WAS OBSERVED AT A PRE-USE CHECK. HOWEVER, AFTER INTUBATING IT INTO THE PATIENT USING AN AIRWAY SCOPE, WHEN THE CUSTOMER ATTEMPTED TO PUT AIR INTO IT, HE NOTICED THE CUFF DID NOT INFLATE. ALSO, HE HEARD A SOUND OF AIR LEAKAGE FROM THE PILOT BALLOON. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298698 ↗