Portex 100/199/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 180 adverse event reports that list this exact device (DI 15019315022340), received between Feb 24, 2017 and Sep 25, 2026 — classified as 27 injuries, 153 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (75 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 180 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50904985 ↗
• MalfunctionSep 17, 2026Inflation Problem

  It was stated that the cuff kept deflating. Re-inflated but the pressure did not hold and deflated slowly. There was no reported patient involvement or harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50803993 ↗
• MalfunctionJul 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PORTEX TRACHEAL TUBE CLEAR MURPHEY EYESOFT SEAL HAD A LEAKAGE ISSUE WHEREIN THE PATIENT UNDERWENT ROUTINE UNEVENTFUL GENERAL ANESTHESIA (GA) AND TRACHEAL INTUBATION AND WAS VENTILATING WELL THEN. LATER, A LEAK (~200ML VOLUME) DEVELOPED AROUND THE TUBE TOWARDS THE END OF THE CASE. ADDITION OF FURTHER AIR DID NOT STOP THE LEAK FOR MORE THAN A FEW SECONDS. UPON LATER INSPECTION (DURING UNDERWATER TESTING), IT BECAME APPARENT THAT THE LEAK ORIGINATED FROM WHERE THE TUBE MEETS THE PROXIMAL PORTION OF THE CUFF. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED HARM OR ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25736064 ↗
• MalfunctionJun 12, 2026Fluid/Blood Leak

  AN EVENT INVOLVING AN ENDOTRACHEAL TUBE REPORTED THAT CUFF LEAKED DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25484789 ↗
• MalfunctionMay 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INTUBATION IN THE EMERGENCY DEPARTMENT AND TRANSFER TO THE ICU, AN AIR LEAK WAS OBSERVED FROM THE CUFF. THE EVENT OCCURRED DURING USE AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25153433 ↗
• MalfunctionApr 23, 2026Gas/Air Leak

  IT WAS STATED THAT THE INTENSIVE CARE UNIT REPORTEDLY ENCOUNTERED A LEAK AT THE JUNCTION WITH THE BALLOON. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24965843 ↗
• MalfunctionApr 2, 2026Failure to Deflate

  IT WAS REPORTED THAT THE CUFF WAS UNABLE TO BE DEFLATED AND COULD NOT PERFORM EXTUBATION. IN ADDITION, FLUID HAD ACCUMULATED WITHIN THE CUFF. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24770826 ↗
• MalfunctionMar 31, 2026Gas/Air Leak

  IT WAS STATED THAT THE CUFF WAS NOT RETAINING AIR TO STAY INFLATED. NO HOLE IN CUFF BUT POORLY ATTACHED OR SEALED TO MAIN PART OF ENDOTRACHEAL TUBE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747404 ↗
• MalfunctionMar 6, 2026Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAK; THE CUFF IS DEFLATING. THERE WAS PATIENT INVOLVEMENT, AND NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533138 ↗
• MalfunctionFeb 18, 2026Gas/Air Leak

  IT WAS STATED THAT THE ISSUE OF THE PRODUCT IS THE LEAKING CUFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379971 ↗
• MalfunctionFeb 17, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT'S ENDOTRACHEAL TUBE (ETT) CUFF WAS LEAKING DURING THE NIGHT, RESULTING IN ONGOING REDUCTION OF CUFF PRESSURE. PER REPORTER, THE LEAK CONTINUED AND THE PATIENT BECAME UNSTABLE, PROMPTING A TUBE EXCHANGE. REPORTER STATED THAT DURING THE EXCHANGE, DUE TO THE PATIENT AIRWAY SWELLING AND DIFFICULT ANATOMY, A CODE BLUE WAS ACTIVATED. THE ANESTHETIC TEAM ARRIVED AND SUCCESSFULLY INSERTED ANOTHER SIZE 8 ETT USING A HIGH-PROFILE VENTILATOR AND GLIDESCOPE. UPON EXAMINING THE DEFECTIVE ETT, THEY DID NOT OBSERVE ANY OBVIOUS EXTERNAL DAMAGE. HOWEVER, DURING A LEAK TEST WITH WATER, A SIGNIFICANT LEAK WAS NOTED AT THE CONNECTION BETWEEN THE TUBE AND THE BALLOON.

  Patient problems: Respiratory Arrest; Swelling/ Edema; Unintended Extubation

  MAUDE report 24370097 ↗
• MalfunctionFeb 16, 2026Gas/Air Leak

  IT WAS STATED THAT THE INTENSIVE CARE UNIT REPORTEDLY ENCOUNTERED A LEAK AT THE JUNCTION WITH THE BALLOON. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345158 ↗
• MalfunctionFeb 5, 2026Gas/Air Leak

  IT WAS REPORTED THAT DURING INTUBATION, THE ETT WAS NOTED TO BE MALFUNCTIONING WITH COMPROMISED CUFF INTEGRITY, RESULTING IN A PERSISTENT AIR LEAKED AND INADEQUATE SEALING. THE DEVICE WAS DEEMED UNFIT FOR USE AND WAS PROMPTLY REPLACED TO ENSURE PATIENT SAFETY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT THE HOSPITAL. THE OUTCOME OF THE EVENT WAS RESOLVED. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24271834 ↗
• MalfunctionFeb 3, 2026Gas/Air Leak

  IT WAS REPORTED THAT LEAK WAS HEARD FROM THE BALLOON AND UNABLE TO CUFF UP. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24249049 ↗
• MalfunctionJan 29, 2026Inflation Problem; Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THERE WAS AN INABILITY TO INFLATE THE BALLOON, AS IT WAS PERFORATED AND DOES NOT RETAIN AIR. REPORTER STATED THAT THE PRODUCT DEFECT WAS IDENTIFIED JUST AFTER INITIAL USE, AND THE BALLOON DID NOT INFLATE. PER REPORTER, THERE WAS NO IDENTIFICATION OF A PROBLEM BEFORE THE INTRODUCTION OF THE DEVICE. PER REPORTER, THE PATIENT WAS RE-INTUBATED WITH A NEW ENDOTRACHEAL TUBE TO STABILIZE THE PATIENT, AS THE PATIENT WAS UNSTABLE AS THE RESULT OF RESPIRATORY DISTRESS. THE PATIENT REMAINED IN INTENSIVE CARE AS THE RESULT OF THE RESPIRATORY ISSUES. THE CUSTOMER ALLEGED THAT THE BALLOON WAS PUNCTURED, RESULTING IN THE INABILITY FOR THE BALLOON TO SWELL UPON INTUBATION.

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 24208577 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE PATIENT WAS INTUBATED, THERE WAS A LEAK IN THE CUFF. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199264 ↗
• MalfunctionJan 28, 2026Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE PATIENT WAS INTUBATED, THERE WAS A LEAK IN THE CUFF. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199261 ↗
• MalfunctionJan 21, 2026Deflation Problem

  IT WAS REPORTED THAT THE ENDO TRACHEAL TUBE DEFLATED DUE TO MANUFACTURER ERROR, DURING INDUCTION. THERE WERE PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131927 ↗
• MalfunctionJan 6, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE HAD A SPLIT. THERE WAS UNKNOWN PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23974496 ↗
• MalfunctionJan 5, 2026Leak/Splash

  IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE CUFF WAS CHECKED PRIOR TO USE, AND THERE WERE NO ISSUES. IT WAS INSERTED WITH EASE BUT DEVELOPED CUFF LEAK 35 MINS POST-INSERTION. IT WAS A SLOW LEAK- THE PILOT BALLOON DEFLATED. THE ENDOTRACHEAL TUBE HAD TO BE CHANGED IN ORDER TO CONTINUE THE PROCEDURE. AFTER CHECKING THE FAULTY CUFF, IT HAD FLUID AND COULD SEE A LEAK BUBBLING FROM A HOLE AROUND THE JUNCTION WHERE THE CUFF HAD BEEN WELDED TO THE MAIN BODY OF THE TUBE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967374 ↗
• MalfunctionDec 31, 2025Deflation Problem; Fluid/Blood Leak; Gas/Air Leak; Deflation Problem; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED IN THE ENDOTRACHEAL TUBE WITH A SOFT SEAL CUFF APPROXIMATELY FOUR HOURS AFTER INTUBATION, WHICH REQUIRED RE-INTUBATION. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937491 ↗
• MalfunctionDec 31, 2025Deflation Problem; Fluid/Blood Leak; Gas/Air Leak; Deflation Problem; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED IN THE ENDOTRACHEAL TUBE WITH A SOFT SEAL CUFF APPROXIMATELY FOUR HOURS AFTER INTUBATION, WHICH REQUIRED RE-INTUBATION. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937461 ↗
• MalfunctionDec 31, 2025Deflation Problem; Fluid/Blood Leak; Gas/Air Leak; Deflation Problem; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED IN THE ENDOTRACHEAL TUBE WITH A SOFT SEAL CUFF APPROXIMATELY FOUR HOURS AFTER INTUBATION, WHICH REQUIRED RE-INTUBATION. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937408 ↗
• MalfunctionDec 31, 2025Deflation Problem; Fluid/Blood Leak; Gas/Air Leak; Deflation Problem; Fluid/Blood Leak; Gas/Air Leak

  IT WAS REPORTED THAT A LEAK WAS OBSERVED IN THE ENDOTRACHEAL TUBE WITH A SOFT SEAL CUFF APPROXIMATELY FOUR HOURS AFTER INTUBATION, WHICH REQUIRED RE-INTUBATION. THERE WAS NO REPORTED PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23937371 ↗
• MalfunctionDec 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS STATED THAT THE PATIENT WAS INTUBATED IN THE OP ROOM, TRANSPORTED TO THE ICU AFTER THE SURGERY, AND PERFORMED RESPIRATORY MANAGEMENT WITH AN ARTIFICIAL RESPIRATOR, A LEAK ALARM OCCURRED, AND WHEN INVESTIGATED, IT WAS CONFIRMED THAT THERE WAS A LEAK OF AIR FOUND FROM THE TOP OF THE CUFF OF THE INNER TRACHEAL TUBE. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23899809 ↗