Portex 100/179/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 15019315022135), received between Aug 16, 2018 and Jun 10, 2026 — classified as 15 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (37 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 55 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAKAGE NOTED IN A TRACHEAL TUBE. THE EVENT WAS NOTED DURING PATIENT USE, AND THERE WAS NO PATIENT HARM OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25459151 ↗
• InjuryApr 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT A PATIENT WAS ADMITTED TO THE ORTHOPEDIC NEUROLOGY DEPARTMENT DUE TO "RIGHT HIP JOINT PAIN FOR 3 HOURS AFTER FALLING". DURING HOSPITALIZATION, PNEUMONIA AND RESPIRATORY FAILURE OCCURRED, WHICH WERE ASSESSED TO BE IN LINE WITH THE INDICATIONS OF MECHANICAL VENTILATION SUPPORT FOR INVASIVE VENTILATION TRACHEAL INTUBATION THERAPY. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT FOR INVASIVE VENTILATION SUPPORT USING THE TRACHEAL INTUBATION. ON (B)(6) 2026, A LEAK WAS DETECTED IN THE ENDOTRACHEAL TUBE CUFF. BRONCHOSCOPIC EXAMINATION REVEALED THE ASPIRATION OF OROPHARYNGEAL SECRETIONS AND GASTRIC CONTENTS INTO THE AIRWAY, THEREBY EXACERBATING THE PATIENT'S PULMONARY INFECTION. THE ENDOTRACHEAL TUBE WAS SUBSEQUENTLY REPLACED. FOLLOWING THE REPLACEMENT, NO FURTHER ASPIRATION OF OROPHARYNGEAL SECRETIONS OR GASTRIC CONTENTS INTO THE AIRWAY WAS OBSERVED.

  Patient problems: Aspiration/Inhalation

  MAUDE report 24794788 ↗
• MalfunctionJan 9, 2026Gas/Air Leak

  THE PATIENT EXPERIENCES SEVERE SHORTNESS OF BREATH THAT WAS NOT RELIEVED, WITH A PROGRESSIVELY INCREASING HEART RATE, GRADUALLY RISING TO 145 BEATS PER MINUTE. A RE-EXAMINATION OF ARTERIAL BLOOD GAS ANALYSIS SHOWS PH: 7.23, PCO2: 77 MMHG, PO2: 89 MMHG, INDICATING THAT THE IMPROVEMENT IN TYPE II RESPIRATORY FAILURE SINCE ADMISSION WAS NOT IDEAL. CONSIDERING THE PATIENT'S POOR CARDIOPULMONARY FUNCTION, AN ENDOTRACHEAL INTUBATION WAS IMMEDIATELY PERFORMED FOR VENTILATOR-ASSISTED BREATHING. BRONCHOSCOPY REVEALED A CONSIDERABLE AMOUNT OF YELLOW-WHITE STICKY SPUTUM IN THE AIRWAY, OBVIOUS AIRWAY SPASM, AND MUCOSAL CONGESTION AND EDEMA. SUCTIONING CAUSED EASY BLEEDING. THE VENTILATOR FREQUENTLY ALARMED, AND AN AIR LEAK FROM THE ENDOTRACHEAL TUBE WAS DETECTED, SO IT WAS IMMEDIATELY REMOVED AND DISCONTINUED. A SIZE 7 NASOTRACHEAL INTUBATION WAS PERFORMED INSTEAD, AND THE PATIENT WAS SUCCESSFULLY RESUSCITATED.

  Patient problems: Dyspnea; Swelling/ Edema; Tachycardia

  MAUDE report 24020335 ↗
• MalfunctionDec 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED IN THE REPORT THAT THE PATIENT PRESENTED WITH CHEST TIGHTNESS, DIFFICULTY BREATHING, LOW PULSE OXIMETRY, AND POOR OXYGENATION. UPON ADMISSION TO THE DEPARTMENT, ENDOTRACHEAL INTUBATION AND MECHANICAL VENTILATION WERE PERFORMED. AFTER SUCCESSFUL INTUBATION, A LEAK WAS DISCOVERED IN THE ENDOTRACHEAL TUBE CUFF, AND THE TUBE WAS IMMEDIATELY REPLACED WITH A NASOTRACHEAL TUBE. NO ADVERSE EFFECTS WERE REPORTED ON THE PATIENT'S HEALTH.

  Patient problems: Chest Pain; Low Oxygen Saturation

  MAUDE report 23768817 ↗
• MalfunctionOct 15, 2025Fluid/Blood Leak; Air/Gas in Device; Fluid/Blood Leak; Air/Gas in Device

  IT WAS REPORTED THAT THE PATIENT'S NASOTRACHEAL (ENDOTRACHEAL) TUBE WAS REPLACED DUE TO AN AIR LEAK IN THE AIRBAG. AFTER PLACING THE NEW TUBE, THE PATIENT WAS CONNECTED TO THE VENTILATOR, AND ALL EQUIPMENT FUNCTIONED NORMALLY WITH NO ALARMS. HOWEVER, UPON FURTHER INSPECTION, THE AIRBAG WAS AGAIN FOUND TO BE LEAKING. THE TUBE WAS THEN REMOVED AND REPLACED WITH ANOTHER NEW ONE. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: Cough

  MAUDE report 23279238 ↗
• MalfunctionAug 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER CHECKING THE BALLOON UPON INFLATING THE ENDOTRACHEAL TUBE BALLOON, IT WAS FOUND THAT THE BALLOON WAS LEAKING AND WAS REPLACED IT WITH A NEW ONE. THE EVENT OCCURRED WHILE IN USE WITH A PATIENT, AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895789 ↗
• MalfunctionAug 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE CHECKED THE ENDOTRACHEAL TUBE BALLOON BEFORE REPLACING THE NASOTRACHEAL TUBE AND FOUND NO OBVIOUS AIR LEAKAGE. SHE ASSISTED THE DOCTOR TO REPLACE THE NASOTRACHEAL TUBE UNDER THE FIBEROPTIC BRONCHOSCOPY AND ADJUSTED THE BALLOON PRESSURE TO 30MNHG. AT 16:00, THE MID-SHIFT NURSE TOOK OVER AND MEASURED THE BALLOON PRESSURE DROP AND READJUSTED IT. AFTER THAT, THE BALLOON WAS FOUND TO BE LEAKING SLOWLY IN EACH SHIFT, AND IT HAD TO BE RE-INFLATED 2-4 TIMES. THE NEXT DAY, THEY REPLACED THE NASOTRACHEAL TUBE, REMOVED THE ORIGINAL NASOTRACHEAL, AND RE-INFLATED IT. THE PIPELINE WAS REPLACED AND THE VENTILATOR-ASSISTED BREATHING CONTINUED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22864813 ↗
• MalfunctionAug 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR CHEST TIGHTNESS, DYSPNEA, LOW FINGER PULSE OXYGEN, AND POOR OXYGENATION, THE PATIENT WAS INTUBATED AND VENTILATED, AND IT WAS DISCOVERED THAT THE BALLOON OF THE PATIENT'S TRACHEAL TUBE HAD AN AIRBAG LEAK AND THE PATIENT WAS DYSPNEA AS A RESULT OF THE ISSUE. THE NASOTRACHEAL TUBE WAS IMMEDIATELY REPLACED.

  Patient problems: Dyspnea

  MAUDE report 22784406 ↗
• MalfunctionJul 28, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE EXHIBITED AIR LEAKAGE AT THE EDGE OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630226 ↗
• InjuryJul 14, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED IN THE REPORT THAT THE VENTILATOR OF A 76-YEAR-OLD MALE PATIENT REPEATEDLY SOUNDED THE ALARM THAT THE MINUTE VENTILATION VOLUME WAS TOO LOW. THE DOCTOR FOUND THAT THE ENDOTRACHEAL TUBE BALLOON WAS LEAKING, AND THE ENDOTRACHEAL TUBE WAS URGENTLY REPLACED UNDER THE GUIDANCE OF A FIBEROPTIC BRONCHOSCOPE. AFTER THE TUBE WAS REPLACED, THE ALARM DISAPPEARED, AND THE VENTILATOR VENTILATION RETURNED TO NORMAL. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22496299 ↗
• MalfunctionApr 22, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A TRACH CHANGE, A TRACHEAL TUBE BALLOON LEAK TEST WAS PERFORMED BEFORE INTUBATION, IT WOULD NOT INFLATE AND WAS THEN REPLACED WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886275 ↗
• MalfunctionMar 7, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIRBAG PRESSURE WAS INSUFFICIENT. AFTER HAVING IT RE-PRESSURIZED, THE AIRBAG PRESSURE WAS INSUFFICIENT AGAIN AFTER A WHILE, THERE WAS BLEEDING AND AIR LEAKAGE. THE HEALTHCARE PROVIDER REPLACED IT WITH A NEW ONE AFTER THAT, THERE WAS NO FURTHER AIR LEAKAGE. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21546986 ↗
• MalfunctionJan 30, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING DURING ROUNDS. THE CUFF WAS RE-INFLATED WHILE IN THE PATIENT BUT DEFLATED AGAIN. DUE TO THIS, THE ENDOTRACHEAL TUBE WAS REMOVED AND HIGH FLOW OXYGEN THERAPY WAS GIVEN. THE PATIENT BREATHED 23 TIMES AND THE PULSE OXYGEN WAS ABOVE 97%. THE CUSTOMER STATES THAT THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THE ENDOTRACHEAL TUBE THAT WAS REMOVED FROM THE PATIENT WAS TESTED AND THE AIR LEAK WAS FOUND. THE TUBE WAS THEN DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21278319 ↗
• MalfunctionDec 30, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A PRE-USE TEST PASSED, THE CANNULA WAS PLACED AND INFLATED, AND THE AIR BAG LEAKED. A NEW PRODUCT WAS NEEDED TO REPLACE THE CANNULA. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21043461 ↗
• InjuryDec 12, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS GIVEN ENDOTRACHEAL INTUBATION AND THEN VENTILATED TO ASSIST BREATHING. THE PREOPERATIVE ROUTINE EXAMINATION OF THE BALLOON SHOWED NO AIR LEAKAGE, AND THE PROCESS OF NASOTRACHEAL INTUBATION WAS SMOOTH. THE BALLOON INFLATION WAS FOUND TO BE UNSUCCESSFUL AFTER SUCCESSFUL INTUBATION. THE NASOTRACHEAL TUBE WAS REPLACED IMMEDIATELY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20914821 ↗
• InjuryNov 15, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR LEAKAGE, INJECTED 10ML OF AIR INTO THE AIRBAG, ONE MINUTE LATER IT WAS FOUND THAT THE AIRBAG COLLAPSED, THE PRESSURE OF THE MANOMETER MEASURED THE AIRBAG WAS 5CMH2O. REPLACED THE NASAL CANNULA. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20696233 ↗
• MalfunctionOct 21, 2024Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE ANTERIOR END OF THE CATHETER WAS ABNORMAL, AND IT WAS DIFFICULT TO SHAPE, RESULTING IN TWO UNSUCCESSFUL CANNULATIONS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20495092 ↗
• InjuryOct 21, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE DOCTOR IN THE EMERGENCY INTENSIVE CARE UNIT INTUBATED THE PATIENT, HE FOUND THAT THE AIR BAG WAS LEAKING AFTER SUCCESSFUL INSERTION. HE IMMEDIATELY REMOVED THE TRACHEAL TUBE AND REPLACED IT, AND REINTUBATED THE PATIENT. DUE TO PRODUCT QUALITY ISSUES, THE PATIENT'S PAIN INCREASED, AND THE RESCUE TIME WAS DELAYED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494876 ↗
• MalfunctionOct 1, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT BEFORE THE OPERATION THE NURSE FOUND THAT THE TRACHEAL TUBE AIR BAG WAS LEAKING BEFORE THE OPERATION AND THEN REPLACED IT WITH A NEW ONE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20347568 ↗
• MalfunctionSep 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER A PATIENT FELL THERE WAS AN IMMEDIATE ENDOTRACHEAL INTUBATION WAS DONE AND A NASOTRACHEAL TUBE WAS USED AND FOUND TO HAVE AN AIR LEAKAGE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20301459 ↗
• MalfunctionSep 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED THROUGH THE NASOTRACHEAL TUBE ON (B)(6) 2024 AND BY (B)(6) 2024 THE AIRBAG WAS DISCOVERED TO BE GRADUALLY LEAKING. PER REPORTER, THE PRESSURE OF THE AIRBAG WAS OBSERVED EVERY SHIFT, AND ON (B)(6) 2024, THE LEAKAGE WAS SERIOUS, AND THE DOCTOR ASSISTED IN REPLACING THE NASOTRACHEAL INTUBATION. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193858 ↗
• MalfunctionSep 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR BAG WAS FOUND TO BE LEAKING. THE ATTENDING PHYSICIAN OBSERVED THE PATIENT'S CONDITION AND REMOVED THE NASOTRACHEAL TUBE. THE TRACHEAL TUBE WAS NOT REPLACED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20193694 ↗
• MalfunctionSep 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WITH THE DEVICE THERE WAS A GRADUAL LEAK FROM THE AIRBAG. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145654 ↗
• MalfunctionSep 5, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING NASOTRACHEAL INTUBATION THE AIR BAG WAS FOUND TO BE LEAKING GRADUALLY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20145579 ↗
• MalfunctionAug 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE THE BALLOON WAS INFLATED AFTER THE CATHETERIZATION, AND THE BALLOON WAS FOUND TO BE LEAKING, SO IT WAS REMOVED. THE SECOND ENDOTRACHEAL TUBE THAT PASSED THE AIR LEAK TEST WAS REPLACED, AND THE AIR STILL LEAKED AFTER THE CATHETER WAS INSERTED, SO IT WAS REMOVED. THE THIRD ENDOTRACHEAL TUBE THAT PASSED THE AIR LEAK TEST WAS REPLACED, AND THE AIR STILL LEAKED AFTER THE CATHETER WAS INSERTED, SO IT WAS REMOVED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19967496 ↗