Portex 100/179/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 15019315022128), received between Apr 5, 2018 and Sep 18, 2026 — classified as 6 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (26 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Gas/Air Leak

  It was reported that the patient was switched to a new nasotracheal tube and connected to a ventilator. Later, the ventilator alarm indicated an air leak. The tracheal tube was replaced, and the cuff was found to be damaged. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818128 ↗
• MalfunctionAug 31, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519896 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508708 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50508679 ↗
• MalfunctionAug 28, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50507454 ↗
• MalfunctionJun 24, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER ENDOTRACHEAL INTUBATION AND CONNECTION TO THE VENTILATOR, AN AIR LEAK ALARM OCCURRED. THE PHYSICIAN REPLACED THE TUBE WITH A NEW ONE, AND INSPECTION OF THE REMOVED TUBE REVEALED A DAMAGED CUFF. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25611451 ↗
• MalfunctionMay 12, 2026Break; Gas/Air Leak

  IT WAS REPORTED THAT THE VENTILATOR SUDDENLY ISSUED AN ALARM, INDICATING AN AIR LEAK. THE DOCTOR IMMEDIATELY REPLACED THE TRACHEAL TUBE. SUBSEQUENT INSPECTION REVEALED THAT THE BALLOON OF THE ORIGINAL TRACHEAL TUBE WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150754 ↗
• MalfunctionMay 12, 2026Unintended Deflation

  IT WAS REPORTED THAT UPON ADMISSION TO THE ICU, THE PATIENT WAS EXPERIENCING RAPID SPONTANEOUS BREATHING AND LOW BLOOD OXYGEN SATURATION, WITH INDICATIONS FOR TRACHEAL INTUBATION. THE DOCTOR IMMEDIATELY PERFORMED BEDSIDE TRACHEAL INTUBATION AND CONNECTED THE PATIENT TO A VENTILATOR FOR ASSISTED BREATHING. THE PATIENT'S RESPIRATORY ALARM INDICATED A LOW TIDAL VOLUME. THE DOCTOR CHECKED THE PATIENT'S VITAL SIGNS, WHICH WERE STABLE, AND NOTED THAT THE BREATHING WAS SMOOTH. THERE WAS A SIGNIFICANT DIFFERENCE BETWEEN THE INHALED TIDAL VOLUME AND THE EXHALED TIDAL VOLUME. AFTER THE BAG WAS INFLATED, IT QUICKLY DEFLATED, SUGGESTING AN AIR LEAK IN THE BAG. THEREFORE, THE TRACHEAL TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150744 ↗
• MalfunctionMay 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER REPLACING THE INTUBATION, THE NEW INTUBATION BALLOON LEAKED AND DID NOT REACH NORMAL PRESSURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25150481 ↗
• MalfunctionApr 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT IMMEDIATELY AFTER THE PHYSICIAN PERFORMED BEDSIDE ENDOTRACHEAL INTUBATION AND INFLATED THE CUFF, THE VENTILATOR SUDDENLY TRIGGERED AN ALARM. MONITORING OF THE CUFF PRESSURE REVEALED A LEAK; DESPITE MULTIPLE ATTEMPTS TO REINFLATE IT, THE LEAK PERSISTED. THE PHYSICIAN, WHO, AFTER ASSESSING THE PATIENT'S CLINICAL CONDITION, PROCEEDED TO EXTUBATE THE PATIENT. THE ENDOTRACHEAL TUBE WAS REMOVED, AND THE PATIENT'S BLOOD OXYGEN SATURATION WAS CLOSELY MONITORED. OUTCOME FOLLOWING INTERVENTION: NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24795096 ↗
• MalfunctionFeb 5, 2026Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT PATIENT HAD A POOR ABILITY TO COUGH UP SPUTUM. THE VENTILATOR REPORTED A TIDAL VOLUME THAT WAS TOO LOW, WITH AN OXYGEN SATURATION OF 98%. THE TRACHEAL PRESSURE GAUGE SHOWED VALUES SIGNIFICANTLY BELOW THE NORMAL RANGE. AFTER EVALUATION BY THE DOCTOR, THE ENDOTRACHEAL TUBE WAS IMMEDIATELY REPLACED. FOLLOWING THE REPLACEMENT, THE PATIENT'S VENTILATOR PARAMETERS WERE CONTINUOUSLY MONITORED, AND TIDAL VOLUME GRADUALLY RETURNED TO THE NORMAL RANGE. SUBSEQUENT MONITORING OF THE PATIENT'S VITAL SIGNS SHOWED THAT ALL INDICATORS REMAINED NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24268166 ↗
• MalfunctionJan 13, 2026Decrease in Pressure; Ventilation Problem in Device Environment

  IT WAS REPORTED THAT IN THE REPORT THAT A 77-YEAR-OLD MALE PATIENT BORN ON (B)(6) 1948, DIAGNOSED WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE WITH ACUTE LOWER RESPIRATORY TRACT INFECTION. ON DECEMBER 11, IT WAS NOTED THAT THERE WERE OBVIOUS WHEEZING SOUNDS. TO REMOVE DEEP-SEATED PHLEGM AND CLEAR THE AIRWAY, A BEDSIDE FIBEROPTIC BRONCHOSCOPY WAS PERFORMED. THE BRONCHOSCOPE WAS INSERTED VIA NASAL TRACHEAL INTUBATION. THE TRACHEAL TUBE PACKAGING WAS OPENED, AND THE INTEGRITY OF THE TRACHEAL TUBE CUFF WAS TESTED, REVEALING A CUFF LEAK AIR. THE TRACHEAL TUBE WAS IMMEDIATELY REPLACED, THE PROCEDURE PROCEEDED SMOOTHLY, AND THE CUFF PRESSURE OF THE TRACHEAL TUBE WAS NORMAL DURING TESTING. ON DECEMBER 12, DURING THE WARD ROUND, THE PATIENT'S VITAL SIGNS WERE STABLE. UPON CHECKING THE TUBES, IT WAS FOUND THAT THE TRACHEAL TUBE CUFF PRESSURE WAS BELOW THE NORMAL VALUE. THE TRACHEAL TUBE CUFF WAS REINFLATED, AND AFTER OBSERVING THE CUFF FOR 5 MINUTES, THE PRESSURE WAS STILL BELOW NORMAL. THE DOCTOR WAS IMMEDIATELY NOTIFIED TO REPLACE THE TRACHEAL TUBE, AND THE PROCEDURE WENT SMOOTHLY. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059548 ↗
• MalfunctionDec 8, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR REPLACED THE PATIENT¿S ENDOTRACHEAL TUBE WHEN THE VENTILATOR ALARMED, INDICATING AN AIR LEAK. PER REPORTER, UPON CHANGING THE TRACH TUBE, A RUPTURE AT THE CUFF WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23750948 ↗
• MalfunctionNov 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, AFTER THE INTUBATION, THE DEVICE TRIGGERED AN ALARM, AND INSPECTION REVEALED A LEAK IN THE INTUBATION CUFF. PER REPORTER, THE ALARM STOPPED AFTER IT WAS REPLACED WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594930 ↗
• MalfunctionNov 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, AFTER THE INTUBATION, THE DEVICE TRIGGERED AN ALARM, AND INSPECTION REVEALED A LEAK IN THE INTUBATION CUFF. PER REPORTER, THE ALARM STOPPED AFTER IT WAS REPLACED WITH A NEW ONE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23594925 ↗
• MalfunctionNov 4, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE ICU FOR FURTHER TREATMENT AFTER UNDERGOING BEDSIDE BRONCHOSCOPY-GUIDED TRACHEAL INTUBATION DUE TO RESPIRATORY FAILURE AT 08:00 ON AUGUST 30. DURING A NURSE SHIFT HANDOVER, AN AIR LEAKING WAS FOUND IN THE CATHETER BALLOON, MAKING IT UNUSABLE, AND THE DUTY DOCTOR AND HEAD NURSE WERE NOTIFIED. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465471 ↗
• MalfunctionJul 7, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE NURSE PERFORMED ENDOTRACHEAL INTUBATION ON A 57-YEAR-OLD MALE PATIENT ACCORDING TO THE DOCTOR'S ORDER. AFTER INTUBATION, THE NURSE FOUND THAT THE ENDOTRACHEAL CUFF WAS LEAKING WHEN MONITORING THE CUFF PRESSURE. THE ENDOTRACHEAL TUBE WAS IMMEDIATELY REMOVED, AND THE NURSE RE-INSERTED THE ENDOTRACHEAL TUBE. THE PATIENT'S CONDITION WAS CLOSELY MONITORED, AND NO HARM WAS FOUND TO THE PATIENT.

  Patient problems: Unintended Extubation

  MAUDE report 22413921 ↗
• InjuryJun 18, 2025Tidal Volume Fluctuations; Gas/Air Leak; Tidal Volume Fluctuations; Gas/Air Leak

  IT WAS REPORTED THAT A 41-YEAR-OLD-MALE PATIENT WAS INTUBATED AND CONNECTED TO A VENTILATOR FOR ASSISTED VENTILATION. AFTER A FEW HOURS THE VENTILATOR FREQUENTLY REPORTED LEAKS AND THE TIDAL VOLUME DECREASED. PER REPORTER, AFTER MONITORING THE VENTILATOR CIRCUIT AND TRACHEAL TUBE BAG, AIR BAG LEAKS WERE FOUND. THE ORIGINAL TRACHEAL TUBE WAS REMOVED, AND THEN THE PATIENT WAS INTUBATED AGAIN THROUGH THE NOSE UNDER THE GUIDANCE OF A FIBEROPTIC BRONCHOSCOPY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287411 ↗
• MalfunctionMay 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED USING AN ENDOTRACHEAL TUBE AND CONNECTED TO A VENTILATOR, THE INFLATION BAG INDICATED AN AIR LEAK AND WAS IMMEDIATELY DISCONTINUED. THE SAME WAS TRUE WHEN THE SECOND ENDOTRACHEAL TUBE WAS REPLACED. THE TUBE WAS USED NORMALLY ONLY AFTER THE THIRD ONE WAS REPLACED, RESULTING IN REPEATED MUCOSAL EDEMA IN THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 22014458 ↗
• MalfunctionMay 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE PATIENT WAS INTUBATED USING AN ENDOTRACHEAL TUBE AND CONNECTED TO A VENTILATOR, THE INFLATION BAG INDICATED AN AIR LEAK AND WAS IMMEDIATELY DISCONTINUED. THE SAME WAS TRUE WHEN THE SECOND ENDOTRACHEAL TUBE WAS REPLACED. THE TUBE WAS USED NORMALLY ONLY AFTER THE THIRD ONE WAS REPLACED, RESULTING IN REPEATED MUCOSAL EDEMA IN THE PATIENT.

  Patient problems: Swelling/ Edema

  MAUDE report 22014457 ↗
• InjuryFeb 6, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT'S BLOOD OXYGEN LEVEL DROPPED AT 10:05 AM, AND NASOTRACHEAL INTUBATION WAS PERFORMED AT 10:10 AM (THE AIR BAG LEAKAGE TEST WAS NORMAL). AT 1:16 PM, THE VENTILATOR ALARM WENT OFF, AND THEY CHECKED THE AIR BAG AND FOUND THAT IT WAS LEAKING. THE DOCTOR IMMEDIATELY REPLACED THE ENDOTRACHEAL TUBE. THE PROCESS WENT SMOOTHLY, AND THE PATIENT'S VITAL SIGNS WERE STABLE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21322572 ↗
• InjuryJan 28, 2025Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  IT WAS REPORTED THE PATIENT'S BLOOD OXYGEN SATURATION DROPPED TO 85%, AND A LARGE AMOUNT OF LIGHT BLOODY FLUID WAS SUCKED OUT OF THE MOUTH AND PHARYNX. THE DOCTOR PERFORMED AN EMERGENCY NASOTRACHEAL INTUBATION. AFTER THE NASOTRACHEAL INTUBATION WAS SUCCESSFULLY INSERTED, WHEN THE BALLOON WAS FIXED, IT WAS FOUND THAT THE INFLATION END OF THE TRACHEAL INTUBATION BALLOON COULD NOT BE INFLATED AND WAS IN AN EMPTY STATE. AFTER EVALUATION, THE NASOTRACHEAL INTUBATION BALLOON MAY HAVE QUALITY PROBLEMS SUCH AS LEAKAGE. TO ENSURE THE PATIENT'S NORMAL VENTILATION, THE NASOTRACHEAL INTUBATION WAS REPLACED. WHEN THE NASOTRACHEAL INTUBATION WAS REMOVED, IT WAS FOUND THAT THE BALLOON AT THE END OF THE TRACHEAL INTUBATION THAT CLOSED THE AIRWAY HAD BEEN INFLATED TO A LARGE AMOUNT AND WAS SPHERICAL, BUT THE BALLOON WAS IN AN EMPTY STATE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252729 ↗
• InjuryDec 6, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE BALLOON WAS FOUND TO BE LEAKING AFTER BEING INSERTED INTO THE PATIENT. THE TRACHEAL TUBE WAS PULLED OUT, AND A NEW ONE WAS INSERTED AFTER BEING TESTED FOR AIR LEAKAGE. THE PATIENT WAS ALSO CONNECTED TO A VENTILATOR TO ASSIST WITH BREATHING. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20863916 ↗
• MalfunctionNov 27, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH ""CHEST TIGHTNESS AND PAIN, SHORTNESS OF BREATH FOR HALF A MONTH, AND AGGRAVATED FOR ONE DAY"". DUE TO THE PATIENT'S CARDIOGENIC SHOCK, HYPOXIC-ISCHEMIC ENCEPHALOPATHY, AND POOR ABILITY TO COUGH AND PRODUCE SPUTUM SPONTANEOUSLY, CORONARY ANGIOGRAPHY WAS PLANNED TO BE PERFORMED URGENTLY, AND IN ORDER TO CLEAR THE AIRWAY, ENSURE OXYGEN SUPPLY, AND CLEAR AIRWAY SECRETIONS, THE PATIENT WAS GIVEN BEDSIDE FIBROBRONCHOSCOPIC NASOTRACHEAL INTUBATION AND ALVEOLAR LAVAGE. BEFORE CATHETERIZATION, THE FIRST ENDOTRACHEAL INTUBATION WAS TESTED, AND PASSED, AND THE BALLOON WAS INFLATED AFTER THE CATHETERIZATION, AND THE AIRBAG WAS FOUND TO BE LEAKING, AND THE LEAKY TRACHEAL INTUBATION WAS REMOVED, AND THE ENDOTRACHEAL INTUBATION WITH GOOD QUALITY WAS REPLACED FOR CATHETERIZATION. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Cardiogenic Shock; Chest Pain; Dyspnea; Encephalopathy

  MAUDE report 20799534 ↗
• MalfunctionSep 19, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE DOCTOR CHANGED THE INTUBATION, THE TIDAL VOLUME WAS NOT REACHED AND THE AIR BAG WAS FOUND TO BE LEAKING AFTER EXAMINATION IT WAS REPLACED IMMEDIATELY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20259878 ↗