Portex 100/199/085Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 15019315022357), received between Sep 14, 2018 and Apr 29, 2026 — classified as 4 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (10 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 29, 2026Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAK SOUND HEARD AND TV (TIDAL VOLUME) DECREASED BY 100-200ML. THE INFLATION LINE TRACING THE LEAK WAS TORN OFF AT THE ROOT DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25028465 ↗
• MalfunctionFeb 26, 2026Inflation Problem

  IT WAS REPORTED THAT THE ETT (ENDOTRACHEAL TUBE) NOTED TO NOT INFLATE UPON INSERTION, ETT (ENDOTRACHEAL TUBE) REMOVED AND PATIENT WAS REINTUBATED WITHOUT FURTHER ISSUE. THEATRE INTUBATION UNDER GENERAL ANAESTHESIA WAS BEING ADMINISTERED OR PERFORMED. THERE WAS DELAY IN THERAPY. THE EVENT DID NOT INVOLVE DEATH OR SERIOUS DETERIORATION OF A PERSON. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24462437 ↗
• MalfunctionFeb 2, 2026Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THERE WAS REINTUBATION DUE TO PERSISTENT CUFF LEAK AND CONCERN OVER CUFF INTEGRITY, REPEATED INFLATION OF PILOT BALLOON AND SUBSEQUENT LOSS OF PRESSURE. THERE WAS PATIENT INVOLVEMENT. THERE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24235236 ↗
• MalfunctionFeb 2, 2026Gas/Air Leak

  IT WAS REPORTED THERE WAS REINTUBATION DUE TO A PERSISTENT CUFF LEAK AND CONCERN OVER CUFF INTEGRITY, REPEATED INFLATION OF PILOT BALLOON AND SUBSEQUENT LOSS OF PRESSURE. THERE WAS PATIENT INVOLVEMENT. THERE NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24234716 ↗
• MalfunctionMar 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON IN THE TUBE WAS PUNCTURED. THERE WAS NO PATIENT INVOLVEMENT AND ACCORDING TO CUSTOMER'S REPORT, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619952 ↗
• MalfunctionMar 17, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON IN THE TUBE WAS PUNCTURED. THERE WAS NO PATIENT INVOLVEMENT AND ACCORDING TO CUSTOMER'S REPORT, THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21619858 ↗
• MalfunctionFeb 26, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AIR LEAK IN THE CUFF. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21474480 ↗
• MalfunctionNov 12, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT LEAKAGE WAS FOUND AT THE BLUE PILOT BALLOON, AND IT SHOWED MANY BUBBLES UNDER THE WATER. THE EVENT OCCURRED DURING PRE-TEST. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20664671 ↗
• InjuryJun 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE FAILED TO INFLATE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595638 ↗
• InjuryJun 24, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING USE, THE TRACHEOSTOMY TUBE FAILED TO INFLATE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19595594 ↗
• MalfunctionSep 19, 2023Inflation Problem; Connection Problem; Inflation Problem; Connection Problem

  IT WAS REPORTED THAT DURING PRE-TESTING, THE CUSTOMER TRIED TO INFLATE THE CUFF, BUT THE CONNECTOR WAS DEFORMED AND THE SYRINGE COULD NOT BE ATTACHED. NO ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17777199 ↗
• MalfunctionJun 26, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER NOTICED THE PRODUCT LABEL ON THE PACKAGE READ 100/199/085, BUT THE INTERNAL DIAMETER OF THE ACTUAL PRODUCT IN THE PACKAGE WAS 8.0 MM. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17204064 ↗
• MalfunctionMay 1, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT A WHITE LOOKING POWDER FOUND ON THE BALLOON CUFF OF THE TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16847606 ↗
• MalfunctionMay 1, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER FOUND A HOLE IN IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16842982 ↗
• MalfunctionApr 30, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A WHITE LOOKING POWDER WAS FOUND ON THE BALLOON CUFF OF THE TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841287 ↗
• MalfunctionApr 29, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A FOREIGN WHITE POWDER WAS FOUND ON THE BALLON CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16841257 ↗
• MalfunctionApr 27, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A WHITE LOOKING POWDER FOUND ON THE BALLOON CUFF OF THE TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16823125 ↗
• InjuryApr 25, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: THE CUFF WAS NOT INFLATABLE. THE TUBE WAS CHANGED TO RESOLVE THE ISSUE. NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811595 ↗
• InjuryApr 25, 2023Leak/Splash; Leak/Splash

  ADDITIONAL INFORMATION: THE CUFF WAS NOT INFLATABLE. THE TUBE WAS CHANGED TO RESOLVE THE ISSUE. NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811470 ↗
• MalfunctionApr 4, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE CUSTOMER INSERTED THE PRODUCT INTO THE PATIENT, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16678257 ↗
• MalfunctionDec 28, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, LEAKAGE OF AIR FROM IT WAS OBSERVED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062518 ↗
• MalfunctionNov 8, 2022Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUFF WAS UNABLE TO BE DEFLATED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15752994 ↗
• MalfunctionJun 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE HOSPITAL EXPERIMENTED ON THE PRODUCT AFTER CASES OF MICRO ASPIRATIONS, AND FOUND THAT CUFFS WERE LEAKING. THE FUNCTIONALITY TESTS WERE PERFORMED IN THE PRESENCE OF A SMITHS REP AND IT WAS OBSERVED THAT INFLATED CUFFS SHOWED LEAKS AND BUBBLES WHEN IMMERSED IN TRANSPARENT CONTAINER FILLED WITH WATER. ADDITIONALLY, IT WAS ALLEGED THE SPRING VALVE OF THE PILOT BALLOON WASN?T WORKING RIGHT. THE TEST WAS DONE IN 189 AND 199. THEY BLEW THE CUFF WITH AIR AT 30 CM AS RECOMMENDED ON THE TUBE, THEN DETACHED THE MANOMETER. THEY RECONNECTED THE MANOMETER AND AFTER A SECOND AND OBSERVED THAT THE READING DROPPED 26CM IN SIZE 7 AND 8 ET. THE PRESSURE WAS NOT GETTING STABILIZED AND WAS CONTINUOUSLY DROPPING. THIS IS THE SAME THING THEY ARE EXPERIENCING AT PATIENT BEDSIDE THOUGHT THEY WERE MAINTAINING THE CUFF PRESSURE FOR 3 TIMES A DAY AND STILL HAVING VAP CASE. ALSO TRIED TO USE 199 PLAIN ET AND FOUND THE PRESSURE WAS NOT GETTING STABLE, CONTINUOUSLY DROPPING. THEY USED 10 UNITS TO ASSESS THE FUNCTIONALITY WITH THE SAME OUTCOME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14761037 ↗
• MalfunctionJun 21, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE HOSPITAL EXPERIMENTED ON THE PRODUCT AFTER CASES OF MICRO ASPIRATIONS, AND FOUND THAT CUFFS WERE LEAKING. THE FUNCTIONALITY TESTS WERE PERFORMED IN THE PRESENCE OF A SMITHS REP AND IT WAS OBSERVED THAT INFLATED CUFFS SHOWED LEAKS AND BUBBLES WHEN IMMERSED IN TRANSPARENT CONTAINER FILLED WITH WATER. ADDITIONALLY, IT WAS ALLEGED THE SPRING VALVE OF THE PILOT BALLOON WASN'T WORKING RIGHT. THE TEST WAS DONE IN 189 AND 199. THEY BLEW THE CUFF WITH AIR AT 30 CM AS RECOMMENDED ON THE TUBE, THEN DETACHED THE MANOMETER. THEY RECONNECTED THE MANOMETER AND AFTER A SECOND AND OBSERVED THAT THE READING DROPPED 26CM IN SIZE 7 AND 8 ET. THE PRESSURE WAS NOT GETTING STABILIZED AND WAS CONTINUOUSLY DROPPING. THIS IS THE SAME THING THEY ARE EXPERIENCING AT PATIENT BEDSIDE THOUGHT THEY WERE MAINTAINING THE CUFF PRESSURE FOR 3 TIMES A DAY AND STILL HAVING VAP CASE. ALSO TRIED TO USE 199 PLAIN ET AND FOUND THE PRESSURE WAS NOT GETTING STABLE, CONTINUOUSLY DROPPING. THEY USED 10 UNITS TO ASSESS THE FUNCTIONALITY WITH THE SAME OUTCOME. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760625 ↗
• MalfunctionJul 22, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  FOLLLOW UP REDACTION REQUIRED AND CORRECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12214935 ↗