Portex 100/199/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 163 adverse event reports that list this exact device (DI 55019315022324), received between Aug 4, 2017 and Sep 3, 2026 — classified as 36 injuries, 127 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (43 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 163 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50587125 ↗
• MalfunctionJun 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING LAPAROSCOPIC CHOLECYSTECTOMY, ENDOTRACHEAL TUBE WAS SUCCESSFULLY PLACED ON FIRST ATTEMPT USING VIDEO LARYNGOSCOPY. TOWARDS THE END OF THE PROCEDURE, A SLOW LEAK WAS NOTED DESPITE AN INTACT CUFF, WITH NO EVIDENCE OF LEAK INTO MOUTH OR AROUND VOCAL CORDS; A QUIET HISSING SOUND WAS AUDIBLE AT THE PROXIMAL END OF THE ENDOTRACHEAL TUBE. THE CASE WAS COMPLETED SAFELY WITH INCREASED FLOWS. ON REMOVAL, A DEFECT WAS IDENTIFIED AT THE SITE WHERE THE PILOT TUBE ENTERS THE ENDOTRACHEAL TUBE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT OR USER HARM REPORTED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25415187 ↗
• InjuryMay 20, 2026Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT, DURING A PROCEDURE, AN ANAESTHETIZED PATIENT BECAME HEMODYNAMICALLY UNSTABLE, AND IT WAS FOUND THAT THE ENDOTRACHEAL TUBE (ETT) WAS KINKED. PER REPORTER, AS A RESULT OF THE KINK, FULL VENTILATION WAS NOT BEING PROVIDED TO THE PATIENT RESULTING IN THE PATIENT BECOMING HEMODYNAMICALLY UNSTABLE. REPORTER ALLEGED THE PATIENT EXPERIENCED HYPOXIA DUE TO THE ETT ISSUE AND STATED THE PRODUCT WAS POOR QUALITY/THIN WALLED/SOFT.

  Patient problems: Hemodynamic instability; Hypoxia

  MAUDE report 25231099 ↗
• MalfunctionMay 4, 2026Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A SIGN OF GAS LEAKAGE AFTER THE TRACHEAL TUBE WAS INSERTED TO PATIENT FOR MECHANICAL VENTILATION. THE TRACHEAL TUBE HAD TO BE REMOVED AND REPLACED WITH A NEW ONE TO MAINTAIN VENTILATORY SUPPORT. EXAMINATION OF THE REMOVED TRACHEAL TUBE FOUND GAS LEAKAGE FROM THE JUNCTION BETWEEN THE BALLOON AND TUBE BODY. LEAKAGE OF TRACHEAL TUBE BALLOON MAY LEAD TO INSUFFICIENT VENTILATORY SUPPORT AND INCREASE RISK OF ASPIRATION FOR PATIENT. REPLACEMENT OF TRACHEAL TUBE IS A RISK AS DIFFICULT INTUBATION MAY ENCOUNTER. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25067899 ↗
• MalfunctionApr 21, 2026Inflation Problem

  IT WAS REPORTED THAT THE BALLOON MALFUNCTIONED ON A PATIENT IN THE INTENSIVE CARE UNIT. PER REPORTER, THE PATIENT HAD TO BE REINTUBATED. NO SYMPTOMS WERE ALLEGED AS A RESULT OF THE DEVICE FAILURE AND REINTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938898 ↗
• MalfunctionApr 21, 2026Inflation Problem

  IT WAS REPORTED THAT THE BALLOON MALFUNCTIONED ON A PATIENT IN THE INTENSIVE CARE UNIT. PER REPORTER, THE PATIENT HAD TO BE REINTUBATED. NO SYMPTOMS WERE ALLEGED AS A RESULT OF THE DEVICE FAILURE AND REINTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24938890 ↗
• MalfunctionApr 20, 2026Inflation Problem

  THE CUSTOMER WAS STATED THE CUFF DOES NOT INFLATE DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT. THE EVALUATION OF THE RETURNED DEVICE CONFIRMED THE REPORTED ISSUE THROUGH TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24925398 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. THE CUFF WAS CHECKED BEFORE ANESTHESIA AND WAS THEN TIGHT. ON ONE OCCASION, A LEAK OCCURRED APPROXIMATELY 2 HOURS INTO THE OPERATION AND THE OTHER JUST BEFORE AWAKENING. AS THE OPERATION WAS COMPLETE, THE PATIENT'S TIDAL VOLUMES BECAME SMALLER AND SMALLER AND WITHIN A FEW MINUTES THEY WERE EXTREMELY SMALL AND THE VENTILATOR ALARMED FOR APNEA. MANUAL VENTILATION WAS USED BUT THE PATIENT WAS BREATHING FROM MOUTH. THE CUFF PRESSURE WAS THEN LESS THAN 10. THE CUFF PRESSURE WAS INCREASED TO 30 AND WITHIN A FEW MINUTES DROPPED BACK TO 10. THE PATIENT'S SATURATION NEVER FELL BELOW 97. UPON INSPECTION OF THE TUBE, THE LEAKAGE WAS IDENTIFIED AT THE POINT WHERE THE CUFF IS WELDED OR GLUED TO THE TUBE. DURING A LATER INSPECTION, THE CUFF WAS TIGHT. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401130 ↗
• MalfunctionFeb 20, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WAS LEAKING. THE CUFF WAS CHECKED PRE-ANESTHESIA AND WAS INTACT AND HOLDING PRESSURE. INTUBATION WAS PERFORMED WITHOUT COMPLICATION USING DIRECT LARYNGOSCOPY. DURING THE PROCEDURE, A CUFF LEAK OCCURRED INTRAOPERATIVELY (ONCE APPROXIMATELY 2 HOURS INTO THE OPERATION AND ONCE JUST PRIOR TO EMERGENCE). INSPECTION IDENTIFIED LEAKAGE AT THE JUNCTION WHERE THE CUFF IS BONDED TO THE TRACHEAL TUBE. ADDITIONAL CUFF INFLATION WAS ATTEMPTED BUT THE CUFF WOULD NOT MAINTAIN PRESSURE. THE PATIENT WAS EXTUBATED AND VENTILATED VIA MASK WITH A TWO-HAND TECHNIQUE AND OROPHARYNGEAL AIRWAY. RE-INTUBATION WAS ATTEMPTED USING A VIDEO LARYNGOSCOPE (D-BLADE) WITH MULTIPLE STYLET ATTEMPTS. THE PATIENT WAS VENTILATED BETWEEN ATTEMPTS AND MAINTAINED OXYGEN SATURATION OF 99%. TUBE PLACEMENT WAS CONFIRMED BY ETCO2 AND AUSCULTATION, SECURED, AND THE PROCEDURE CONTINUED WITHOUT FURTHER ISSUE. SUBSEQUENT EXAMINATION OF THE ORIGINAL TUBE CONFIRMED A SIGNIFICANT LEAK AT THE UPPER CUFF ATTACHMENT SITE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24401031 ↗
• MalfunctionFeb 16, 2026Deflation Problem

  IT WAS REPORTED THAT THE BALLOON OF THE PORTEX TRACHEAL TUBE DEFLATED SLOWLY DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344426 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PRODUCT HAD A LEAK IN THE CUFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24202334 ↗
• MalfunctionJan 12, 2026Leak/Splash

  IT WAS REPORTED THAT THE REPEATED CUFF AIRLEAK POST INTUBATION INTERFERING WITH VENTILATION, SO ETT EXCHANGED. IT WAS PRESUMED THAT IT WAS CUFF DAMAGE, BUT LEAK WAS IDENTIFIED AT JUNCTION BETWEEN PILOT BALLOON BLUE TUBING AND ETT. THE EVENT OCCURRED IMMEDIATELY ON USE IN HOSPITAL. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL. THE ISSUE WAS SOLVED BY EXCHANGING THE DEVICE. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24046331 ↗
• MalfunctionDec 18, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TUBES CUFF DEFLATED WHILST IN A PATIENT. THE PATIENT HAD TO BE EXTUBATED AND THEN REINTUBATED. THE REPORTED DEVICE WAS REPLACED WITH ANOTHER ONE AND NO FURTHER PROBLEMS ENCOUNTERED. THERE WAS REPORTED PATIENT INVOLVEMENT BUT NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838728 ↗
• MalfunctionDec 3, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DUE TO SEVERE PNEUMONIA THE PATIENT WAS ADMITTED TO THE HOSPITAL CAUSED BY CHRONIC OBSTRUCTIVE PULMONARY DISEASE, DUE TO A CRITICAL CONDITION, THE PATIENT UNDERWENT ENDOTRACHEAL INTUBATION. AFTER SUCCESSFUL INTUBATION, THE CUFF WAS INFLATED, AND THE PATIENT WAS CONNECTED TO A VENTILATOR. THE PATIENT'S HYPOXIA IMPROVED. AROUND 9:30 AM, THE VENTILATOR ALARM TRIGGERED A LEAK. MEDICAL STAFF FOUND AIR BUBBLES ESCAPING FROM HER MOUTH, INDICATING A DROP IN BLOOD OXYGEN SATURATION AND LIFE-THREATENING HYPOXIA. PRELIMINARY ANALYSIS SUGGESTED THE CAUSE WAS A SLOW LEAK AFTER THE ENDOTRACHEAL INTUBATION CUFF INFLATED. THE STAFF IMMEDIATELY REPLACED THE ENDOTRACHEAL TUBE AND REINTUBATED THE PATIENT. THE VENTILATOR ALARM WAS DEACTIVATED, BLOOD OXYGEN SATURATION STOPPED DECREASING, AND THE HYPOXIC CONDITION IMPROVED. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM WAS REPORTED.

  Patient problems: Hypoxia

  MAUDE report 23709107 ↗
• MalfunctionNov 25, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A CUFF LEAK DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23648500 ↗
• MalfunctionNov 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

  AN EMAIL WAS RECEIVED REGARDING A PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL WITH ITEM NUMBER 100 199 070 AND UNKNOWN LOT NUMBER. IT WAS REPORTED THAT THE BALLOON OF THE INTUBATION PROBE WAS POROUS. THE REPORTER STATED THAT THE FEMALE PATIENT, OF 74 YEARS OLD AND HEIGHT 1.53 M WAS INTUBATED THE SAME MORNING, AT 8:30. AS CONSEQUENCE THE PATIENT WAS RE-SEDATED WITH ATRACURIUM WITH THE RE-INTUBATION IN THE AFTERNOON. THE INCIDENT HAS BEEN RESOLVED. THERE WAS A PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631084 ↗
• MalfunctionAug 22, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED AND THE ENDOTRACHEAL TUBE (ETT) DEFLATED ABOUT AN HOUR INTO THE CASE. PER REPORTER, ON INSPECTION, THE GLUE ATTACHING CUFF TO ETT HAD BECOME LOOSE. THE ETT WAS REPLACED. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22877541 ↗
• MalfunctionJul 29, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED IN THE REPORT THAT THERE WAS AN AIR LEAK FROM THE CUFF OF THEIR SIZE 7 100/199/070 ET TUBE. PER REPORTER, THE LEAK WAS AT THE BASE AND THE CUFF WAS NOT PERFORATED. A VIDEO WAS PROVIDED DEMONSTRATING THE LEAK BY IMMERSING THE ET TUBE IN WATER AND INFLATING THE CUFF ¿ BUBBLES SEEN. THERE WAS NO PATIENT HARM, BUT THE PATIENT NEEDED TO BE REINTUBATED. THE SAMPLE WAS CONTAMINATED AND UNAVAILABLE FOR RETURN. THEY HAVE ONE REMAINING UNOPENED ET TUBE OF THE SAME BATCH AND HAS BEEN QUARANTINED IN CASE THERE IS AN ISSUE. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22643192 ↗
• InjuryJul 18, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THERE WERE ISSUES WITH THE CUFFS DEFLATING DURING THE PROCEDURE. IT WAS STATED THAT THIS ISSUE HAD OCCURRED BEFORE AND THE STAFF HAD TO RE-INTUBATE THE PATIENT. THE STAFF HAD TO CHECK AND FILL THE BALLOONS DURING THE PROCEDURES. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543148 ↗
• MalfunctionJun 19, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE TRACHEAL INTUBATION CUFF. THE DOCTOR IMMEDIATELY REPLACED THE TRACHEAL TUBE WITH A NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292884 ↗
• MalfunctionApr 22, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE VENTILATION OF THE DEVICE WAS POOR SO THE TUBE WAS REPLACED. AFTER TWO WEEKS HAD PASSED SINCE INTUBATION, WHEN AIR WAS PUMPED INTO THE CUFF AND WATER WAS ADDED, THE AIR WAS FOUND TO BE LEAKING FROM THE SEAL AT THE TOP OF THE CUFF. THE EVENT OCCURRED DURING PATIENT USE BUT THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885292 ↗
• MalfunctionApr 22, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE VENTILATION ON THE DEVICE WAS POOR, SO THE TUBE WAS REPLACED. AFTER TWO WEEKS HAD PASSED SINCE INTUBATION, WHEN AIR WAS PUMPED INTO THE CUFF AND WATER WAS ADDED, AIR WAS FOUND TO BE LEAKING FROM THE SEAL AT THE TOP OF THE CUFF. THE EVENT OCCURRED DURING PATIENT USE BUT THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885126 ↗
• MalfunctionApr 3, 2025Inflation Problem; Failure to Deflate; Inflation Problem; Failure to Deflate

  IT WAS REPORTED THAT WHEN ATTEMPTING TO INFLATE THE CUFF, THE PILOT BALLOON BECAME FULL, MAKING IT DIFFICULT TO GET AIR INTO THE CUFF. THE EVENT OCCURRED BEFORE PATIENT USE DURING PRIMING AT THE FACILITY. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21769678 ↗
• MalfunctionMar 20, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON IN THE TUBE WAS PUNCTURED. THE EVEN OCCURRED DURING THE PRE-TEST AND ON ITS IMMEDIATE USE. THERE WAS NO PATIENT HARM OR ADVERSE EFFECTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21657120 ↗
• MalfunctionFeb 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE USER ENCOUNTERED A LEAK WITH A TUBE THAT MAY POTENTIALLY BE A DESIGN FLAW. THE CUFF WAS CHECKED BEFORE ANESTHESIA AND WAS FOUND TO BE INTACT. HOWEVER, AFTER INTUBATION, A LEAKAGE OCCURRED, AND UPON INSPECTION OF THE TUBE, IT WAS FOUND TO BE LEAKING AT THE WELD. THERE WAS PATIENT INVOLVEMENT BUT THE PATIENT HAS REPORTEDLY NOT SUFFERED ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21355340 ↗