Portex 100/166/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 15019315054105), received between Mar 21, 2017 and May 12, 2026 — classified as 11 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (20 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 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAK OF 100 ML PER BREATH. THE CUFF PRESSURE INCREASED, BUT LEAKAGE CONTINUED. FRESH GAS WAS ADMINISTERED, AND THE PROCEDURE WAS COMPLETED WITH THE LEAKING TUBE. MEDICAL INTERVENTION WAS NOT REQUIRED. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153635 ↗
• MalfunctionApr 9, 2026Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATING THE PATIENT, THERE WAS AN AIR LEAK FROM THE CUFF, AND THE CUFF FAILED TO INFLATE DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830691 ↗
• MalfunctionMar 19, 2026Pressure Problem

  IT WAS REPORTED THAT THE ARTIFICIAL RESPIRATION DEVICE TRIGGERED A LOW INSPIRATORY PRESSURE ALARM DURING ENDOTRACHEAL INTUBATION WAS PERFORMED IN THE OPERATING ROOM. THE TUBE WAS REPLACED ACCORDINGLY. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640954 ↗
• MalfunctionMar 19, 2026Pressure Problem

  IT WAS REPORTED VENTILATOR LOW INSPIRATORY PRESSURE ALARM SOUNDED DURING INTUBATED IN THE EMERGENCY DEPARTMENT, CURRENTLY ON MECHANICAL VENTILATION IN THE ICU. TUBE WAS REPLACED WITH A NEW ONE. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640862 ↗
• MalfunctionMar 19, 2026Pressure Problem

  IT WAS REPORTED INTUBATED IN THE EMERGENCY ROOM, 48 HOURS LATER A LOW INSPIRATORY PRESSURE ALARM OCCURRED ON THE VENTILATOR. SUSPECTED CUFF DAMAGE, REPLACED WITH A NEW ONE. THE EVENT OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640843 ↗
• MalfunctionMar 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED IN THE ICU AND EXPERIENCED FREQUENT BUCKING. AN AIR LEAK DEVELOPED WITH INCREASED AIRWAY PRESSURE, WHICH WAS TOO LARGE TO MANAGE, SO THE ENDOTRACHEAL TUBE WAS REPLACED. EXAMINATION REVEALED A LEAK NEAR THE PROXIMAL PORTION OF THE CUFF. THE EVENT OCCURRED DURING USE, AND NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557418 ↗
• MalfunctionJan 23, 2026Gas/Air Leak

  IT WAS REPORTED DURING MECHANICAL VENTILATION, A CUFF LEAK OCCURRED 96 HOURS AFTER INTUBATION. ON-SITE INSPECTION CONFIRMED THAT THE LEAK WAS COMING FROM THE ADHESIVE SURFACE NEAR THE PROXIMAL PART OF THE CUFF. THIS OCCURRED DURING USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24167928 ↗
• MalfunctionJan 6, 2026Deflation Problem; Fluid/Blood Leak; Leak/Splash

  IT WAS REPORTED THAT A LEAK OCCURRED 4 HOURS AFTER INTUBATION. THE TUBE WAS REPLACED, AND THE CUFF WAS CHECKED, REVEALING A LEAK FROM THE PROXIMAL PART OF THE CUFF. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23975078 ↗
• MalfunctionDec 24, 2025Gas/Air Leak; Ventilation Problem in Device Environment; Gas/Air Leak; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT THE ANESTHESIOLOGIST INTUBATED THE PATIENT IN THE OPERATING ROOM WITH MCGRATH AND AFTER SURGERY, THE PATIENT WAS ADMITTED TO THE ICU. WITHIN 24 HOURS OF ADMISSION TO THE ICU, THE PATIENT SHOWED SIGNS OF VENTILATOR ABNORMALITY, AND A CUFF LEAK WAS SUSPECTED, SO THE TUBE WAS REPLACED. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890802 ↗
• MalfunctionDec 17, 2025Leak/Splash; Ventilation Problem in Device Environment; Leak/Splash; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED USING A MCGRATH LARYNGOSCOPE IN THE OPERATING ROOM AND AFTER THE SURGERY, THEY WERE ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND WAS RECEIVING ARTIFICIAL RESPIRATION MANAGEMENT, BUT A LOW-PRESSURE ALARM ON THE VENTILATOR OCCURRED. AIR WAS INJECTED, WHICH SUGGESTED AN AIR LEAK IN THE CUFF, BUT THE CUFF PRESSURE DID NOT INCREASE. A NEW INTUBATION TUBE WAS INSERTED, AND ARTIFICIAL RESPIRATION MANAGEMENT WAS CONTINUED. THE EVENT OCCURRED DURING PATIENT USE/ADMINISTRATION AT FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23829589 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED APPROXIMATELY 48 HOURS AFTER BEING INTUBATED, AND A NEW INTUBATION TUBE WAS PLACED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827166 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED APPROXIMATELY 48 HOURS AFTER BEING INTUBATED, AND A NEW INTUBATION TUBE WAS PLACED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827154 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED APPROXIMATELY 48 HOURS AFTER BEING INTUBATED, AND A NEW INTUBATION TUBE WAS PLACED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827141 ↗
• MalfunctionDec 17, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED APPROXIMATELY 48 HOURS AFTER BEING INTUBATED, AND A NEW INTUBATION TUBE WAS PLACED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827131 ↗
• MalfunctionSep 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING INTUBATION, THE AIR WAS LEAKED. THE PATIENT WAS IMMEDIATELY EXTUBATED, AND NO RE-INTUBATION WAS PERFORMED. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037145 ↗
• MalfunctionAug 28, 2025Deflation Problem; Deflation Problem

  IT WAS STATED THAT THE PILOT BALLOON DEFLATED. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22913135 ↗
• MalfunctionMay 13, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK 48 HOURS AFTER INTUBATION. THE INTUBATION TUBE WAS REPLACED AND UPON CHECKING THERE WAS A PIN HOLE ON THE TOP OF THE CUFF. THE EVENT OCCURRED WHILE PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22009409 ↗
• MalfunctionMay 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22006331 ↗
• MalfunctionApr 4, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUFF WAS, DID NOT INFLATE. THIS OCCURRED DURING PATIENT USE BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21777728 ↗
• MalfunctionMar 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUFF LEAKS TRIGGERED VENTILATOR ALARM IN INTUBATED PATIENT. THERE WAS DISINFECTION OR STERILIZATION USING ALCOHOL, AND NO INFECTIOUS DISEASE OCCURRED. THIS OCCURRED WHILE PATIENT USE. BUT THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676829 ↗
• MalfunctionJan 14, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF DID NOT COMPLETELY INFLATE DURING TESTING (LEAK). THE ISSUE WAS RESOLVED BY CHANGING TO A NEW PRODUCT. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21149174 ↗
• InjuryMar 21, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING INSERTION, AN AIR LEAKAGE WAS OBSERVED. THE DEVICE WAS TAKEN OUT AND SUBMERGED IN WATER WHERE IT WAS FOUND THAT THERE WAS AN AIR LEAK. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587732 ↗
• MalfunctionOct 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK ON THE DEVICE, THE CUSTOMER NOTICED THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635245 ↗
• MalfunctionSep 4, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN INFLATING AND DEFLATING THE CUFF IN A PRE-USE CHECK, THE CUSTOMER FELT SOMETHING WAS WRONG WITH IT. SO HE DID NOT USE THE PRODUCT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353853 ↗
• InjuryAug 3, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE FAILED TO INFLATE THE BALLOON. THE INTUBATION HAD ALL BEEN STRAIGHT FORWARD AND WHEN THE ANESTHETIST AND ODP COULD NOT GET A SEAL THEY HAD TO EXTUBATE AND THEN INTUBATE WITH ANOTHER TUBE. THE ANESTHETIST THEN EXAMINED THE ET TUBE THAT CAUSED THE PROBLEM AND FOUND THAT IT WAS LEAKING AT THE AT THE BOTTOM OF THE INFLATION PORT. THE CUSTOMER THEN SUBMERGED IN WATER AND COULD SEE THAT IT WAS DEFINITELY LEAKING FROM THAT AREA. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL DATED 06-JUL-2022: NO MEDICAL INTERVENTION WAS REQUIRED OTHER THAN CHANGING OUT THE TUBE. PATIENT WAS EXTUBATED AND THEN RE-INTUBATED WITH ANOTHER DEVICE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15160764 ↗