Portex 100/199/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 222 adverse event reports that list this exact device (DI 15019315022333), received between Feb 8, 2017 and Sep 30, 2026 — classified as 4 deaths, 35 injuries, 183 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (57 reports).

6 other recalls cover devices cleared under the same FDA submission (K790312); they may or may not involve this specific model.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 222 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Air/Gas in Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50952824 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Code Blue, the patient had no heartbeat and Cardiopulmonary Resuscitation (CPR) and intubation were initiated. During an intubation attempt, the tracheal tube cuff inflation bulb reportedly burst, preventing cuff inflation and causing a delay of less than five minutes. Ventilation was maintained with a BVM/Ambu bag between attempts. Return of Spontaneous Circulation (ROSC) was not achieved, and the patient expired. The reporter stated that the death was not related to the device; however, patient harm was reported, while noting that it has not been established whether the harm was caused by our device.

  Patient problems: Insufficient Information

  MAUDE report 50937144 ↗
• DeathSep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that during a Code Blue, the patient had no heartbeat and Cardiopulmonary Resuscitation (CPR) and intubation were initiated. During an intubation attempt, the tracheal tube cuff inflation bulb reportedly burst, preventing cuff inflation and causing a delay of less than five minutes. Ventilation was maintained with a BVM/Ambu bag between attempts. Return of Spontaneous Circulation (ROSC) was not achieved, and the patient expired. The reporter stated that the death was not related to the device; however, patient harm was reported, while noting that it has not been established whether the harm was caused by our device.

  Patient problems: Insufficient Information

  MAUDE report 50937075 ↗
• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50905008 ↗
• MalfunctionSep 9, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680908 ↗
• MalfunctionSep 9, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50680905 ↗
• MalfunctionSep 8, 2026Material Separation

  It was reported that, during a bronchoscopy procedure performed through an endotracheal tube in a patient receiving invasive mechanical ventilation, fragments were observed detaching from the inner lumen of the tube. The customer indicated that it was unknown whether any detached fragments had been inhaled by the patient. A replacement probe was inserted after the detached elements were identified. The event involved a patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50671191 ↗
• MalfunctionJul 8, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25747923 ↗
• MalfunctionJun 24, 2026Gas/Air Leak

  IT WAS REPORTED THAT DUE TO CARBON DIOXIDE RETENTION, OROTRACHEAL INTUBATION WAS PERFORMED ON (B)(6) 2026, WITHOUT COMPLICATIONS. ON (B)(6) 2026, STRIDOR WAS HEARD DURING ROUNDS, AND A CUFF LEAK WAS DETECTED. THE CUFF WAS REINFLATED TO 30 CMH2O, BUT STRIDOR RECURRED TWO MINUTES LATER. SUSPECTING A CUFF LEAK, THE ENDOTRACHEAL TUBE WAS REPLACED. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES. THE FAILURE MODE WAS FOUND IN CLINICAL CONDITIONS. THEREFORE, IF THE EVENT RECURS DURING VENTILATION, IT WILL INTERRUPT THERAPY AND POTENTIALLY IMPACT THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25608852 ↗
• MalfunctionMay 21, 2026Deflation Problem; Unintended Deflation

  AN EMAIL WAS RECEIVED REGARDING A SDE ENDOTRACHEALE, WITH ITEM NUMBER: 100 199 075 AND UNKNOWN LOT NUMBER. IT WAS STATED THAT THE CUFF DEFLATED WITHIN APPROXIMATELY 5 SECONDS DUE TO A DEFECTIVE ORANGE VALVE. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244561 ↗
• MalfunctionMay 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING SLOWLY. PER REPORTER, PATIENT HAD TO BE REINTUBATED TWICE WITHIN 24 HOURS DUE TO THIS ISSUE. REPORTER STATED THAT THE PATIENT WAS SEDATED AND DID NOT CAUSE THE LEAKS. REPORTER STATED THAT CUFF PRESSURE WAS MAINTAINED UNTIL THE TUBE WAS EXCHANGED. NO PATIENT HARM/ADVERSE EVENT WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176790 ↗
• MalfunctionMay 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING SLOWLY. PER REPORTER, PATIENT HAD TO BE REINTUBATED TWICE WITHIN 24 HOURS DUE TO THIS ISSUE. REPORTER STATED THAT THE PATIENT WAS SEDATED AND DID NOT CAUSE THE LEAKS. REPORTER STATED THAT CUFF PRESSURE WAS MAINTAINED UNTIL THE TUBE WAS EXCHANGED. NO PATIENT HARM/ADVERSE EVENT WAS ALLEGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25176783 ↗
• MalfunctionMay 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED WITH A 7.5 PORTEX ENDOTRACHEAL TUBE AND THE CUFF RUPTURED DURING USE. PER REPORTER, THE VENTILATOR WAS ALARMING CONTINUOUSLY IN THE EVENING ON THE DAY OF INTUBATION, AND IT WAS FOUND THAT THE TIDAL VOLUMES WERE LOW, SO THE RESPIRATORY THERAPIST PLACED THE CUFFLATOR ON THE PILOT BALLOON AND INFLATED IT. REPORTER STATED THAT AIR WAS REPEATEDLY ADDED TO THE CUFF TO ASSIST WITH VENTILATION, PROMPTING A RAPID RESPONSE. THERE WAS ABOUT A 30-MINUTE DELAY AND THE ENDOTRACHEAL TUBE WAS REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25172931 ↗
• MalfunctionMay 11, 2026Material Rupture

  IT WAS REPORTED THAT THE PATIENT WAS INTUBATED IN THE EMERGENCY DEPARTMENT AND THEN TRANSFERRED TO THE INTENSIVE CARE UNIT. AT THE TIME OF INSERTION, NO ABNORMALITIES WERE OBSERVED; HOWEVER, THE FOLLOWING DAY THE CUFF WAS FOUND TO BE RUPTURED. PATIENT ADVERSE EFFECTS WERE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25142896 ↗
• MalfunctionMay 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT PRIOR TO PLACEMENT, THE BALLOON WAS CHECKED BY THE NURSE AND FOUND TO BE FUNCTIONAL. AFTER 24¿36 HOURS OF USE, A LEAK WAS OBSERVED, DETECTED VIA VENTILATOR ALARMS AND AUDIBLE BREATHING SOUNDS FROM THE PATIENT¿S MOUTH. SEVERAL REINFLATION ATTEMPTS WERE PERFORMED; HOWEVER, THE BALLOON CONTINUED TO DEFLATE SPONTANEOUSLY. DUE TO THE RECURRENT BALLOON DEFLATION, REPLACEMENT WITH A LARGER-CALIBER PROBE WAS REQUIRED, POTENTIALLY EXPOSING THE PATIENT TO A RISK OF TRAUMA. PATIENT CONSEQUENCES: NO INJURY BUT NEED TO RE-INTUBATE THE PATIENT, USING A LARGER PROBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25061484 ↗
• InjuryApr 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT ON MAR 16 (MON) THE PATIENT WAS INTUBATED IN THE EMERGENCY ROOM. A DECREASE IN CUFF PRESSURE WAS OBSERVED ON MARCH 28, BUT SINCE IT WAS A HOLIDAY AND IT WAS DIFFICULT FOR A DOCTOR TO RESPOND, AIR WAS INJECTED USING A CUFF PRESSURE GAUGE FREQUENTLY, AND USE WAS CONTINUED. A VENTILATOR LEAK ALARM OCCURRED ON MARCH 30, SO THE TUBE WAS REPLACED WITH A NEW ONE. UPON CHECKING THE TUBE AFTER EXTUBATING, A LEAK WAS CONFIRMED FROM THE ADHESIVE PART AT THE TOP OF THE CUFF. THE EVENT OCCURRED DURING USE. THERE WAS AFTEREFFECT REPORTED. FREQUENT CUFF PRESSURE ADJUSTMENTS, TUBE REPLACEMENTS PERFORMED. THE PATIENT IS EXPERIENCING O2 DECREASE, VAP. THE CAUSALITY BETWEEN THE ITEM AND THE DISEASE CANNOT BE DENIED. THE PATIENT HAD NOT RECOVERED AT THE TIME OF REPORTING.

  Patient problems: Low Oxygen Saturation; Unintended Extubation

  MAUDE report 24932902 ↗
• MalfunctionApr 14, 2026No Pressure

  IT WAS REPORTED DURING INTUBATION IN THE TRAUMA UNIT; THE BALLON'S PRESSURE WAS REMOVED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THE OPERATOR OF THE DEVICE IS A HEALTH PROFESSIONAL. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24880319 ↗
• MalfunctionApr 14, 2026Gas/Air Leak

  IT WAS REPORTED THAT AN 87-YEAR-OLD MALE PATIENT EXPERIENCED SUDDEN RESPIRATORY AND CARDIAC ARREST. THE DOCTOR PERFORMED TRACHEAL INTUBATION AT THE BEDSIDE DURING EMERGENCY RESUSCITATION. DURING THE PROCEDURE, AN AIR LEAK WAS FOUND IN THE TRACHEAL TUBE, AND THE TRACHEAL TUBE WAS IMMEDIATELY REPLACED TO COMPLETE THE RESUSCITATION EFFORTS. THE PATIENT WAS LATER TRANSFERRED TO THE ICU FOR CONTINUED TREATMENT.

  Patient problems: Cardiac Arrest; No Clinical Signs, Symptoms or Conditions; Respiratory Arrest

  MAUDE report 24872864 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS STATED THAT THE BALLOON ON ENDO TRACHEAL TUBE (ETT) FAILED. ONGOING LEAK NOTED POST ARRIVAL OF PATIENT FROM KINGAROY HOSPITAL OVERNIGHT. PATIENT ADMITTED TO CCW FROM KINGAROY, ALREADY INTUBATED AND VENTILATED. DIFFICULTY MAINTAINING CUFF PRESSURES POST ARRIVAL, HOWEVER AWAITED APPROPRIATE TIME OF DAY TO FACILITATE ETT EXCHANGE (DURING DAYTIME HOURS), GIVEN THAT PATIENT VENTILATION WAS STABLE. THE EVENT OCCURRED POST INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401180 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MINOR LEAKAGE WAS NOT DETECTED DURING THE LEAK TEST. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED DECREASED OXYGEN SATURATION WHILE ON THE VENTILATOR AND WAS IDENTIFIED A VENTILATION LEAK FROM THE ENDOTRACHEAL TUBE (ETT). AFTER REINTUBATION AND WATER TESTING OF THE ENDOTRACHEAL TUBE (ETT) CUFF, AN EXISTING CUFF LEAK WAS CONFIRMED. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882573 ↗
• MalfunctionDec 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT MINOR LEAKAGE WAS NOT DETECTED DURING THE LEAK TEST. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED DECREASED OXYGEN SATURATION WHILE ON THE VENTILATOR AND WAS IDENTIFIED A VENTILATION LEAK FROM THE ENDOTRACHEAL TUBE (ETT). AFTER REINTUBATION AND WATER TESTING OF THE ENDOTRACHEAL TUBE (ETT) CUFF, AN EXISTING CUFF LEAK WAS CONFIRMED. THERE WAS A PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23882509 ↗
• MalfunctionDec 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT DURING THE LEAK TEST, THE MINOR LEAKAGE WAS NOT DETECTED. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION WHILE ON THE VENTILATOR. BASED ON THE INVESTIGATION, A VENTILATION LEAK FROM THE ETT WAS IDENTIFIED. AFTER REINTUBATION AND MONITORING OF THE ETT CUFF USING WATER, IT WAS FOUND THAT THE ETT CUFF HAD BEEN LEAKING. THE EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786578 ↗
• MalfunctionDec 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT DURING THE LEAK TEST, THE MINOR LEAKAGE WAS NOT DETECTED. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION WHILE ON THE VENTILATOR. BASED ON THE INVESTIGATION, A VENTILATION LEAK FROM THE ETT WAS IDENTIFIED. AFTER REINTUBATION AND MONITORING OF THE ETT CUFF USING WATER, IT WAS FOUND THAT THE ETT CUFF HAD BEEN LEAKING. THE EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786565 ↗
• MalfunctionDec 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT DURING THE LEAK TEST, THE MINOR LEAKAGE WAS NOT DETECTED. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION WHILE ON THE VENTILATOR. BASED ON THE INVESTIGATION, A VENTILATION LEAK FROM THE ETT WAS IDENTIFIED. AFTER REINTUBATION AND MONITORING OF THE ETT CUFF USING WATER, IT WAS FOUND THAT THE ETT CUFF HAD BEEN LEAKING. THE EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23786537 ↗
• MalfunctionDec 11, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT DURING THE LEAK TEST, THE MINOR LEAKAGE WAS NOT DETECTED. HOWEVER, WITHIN 24 HOURS, THE PATIENT EXPERIENCED A DROP IN OXYGEN SATURATION WHILE ON THE VENTILATOR. BASED ON THE INVESTIGATION, A VENTILATION LEAK FROM THE ETT WAS IDENTIFIED. AFTER REINTUBATION AND MONITORING OF THE ETT CUFF USING WATER, IT WAS FOUND THAT THE ETT CUFF HAD BEEN LEAKING. THE EVENT OCCURRED AT HOSPITAL WHILE IN USE WITH PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23784617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K790312. One submission often covers many models, so check the product and lot details in each record.

• Z-1289-2025 · Feb 13, 2025 · Open, Classified
  Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025
• Z-2538-2014 · Jul 7, 2014 · Terminated
  H4002PS Neonatal/Paed.Intubation Kit 3.0mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-2537-2014 · Jul 7, 2014 · Terminated
  H4001S Neonatal/Paed.Intubation Kit 2.5mm Murphy,15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-2536-2014 · Jul 7, 2014 · Terminated
  4001PS Neonatal/Paed.Intubation Kit 2.5mm Murphy, LDS 15mm Conn Pediatric Endotracheal Intubation Kit
• Z-2539-2014 · Jul 7, 2014 · Terminated
  H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
• Z-1641-2014 · Apr 10, 2014 · Terminated
  Portex Low Dead Space Connector with Sideport, 3.5mm Product Usage: The connector is used to attach the endotracheal tube to the patient breathing circuit. The low dead space con