Portex 100/179/055Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 15019315022098), received between Apr 13, 2022 and Jun 18, 2025 — classified as 2 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NASAL SOFT-SEAL CUFF ON THE TRACHEAL TUBE WAS LEAKING. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22286932 ↗
• InjuryJun 12, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKS, AND IT HAPPENED BEFORE. THE PATIENT WAS INTUBATED WITH A CUFF, AND THERE WAS LEAK. THE CUFF WAS TESTED WITH A CUFF PRESSURE GAUGE. THE TUBE WAS CHANGED WITH ANOTHER 5.5 TUBE, AND IT WORKED WITHOUT PROBLEMS. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22194758 ↗
• MalfunctionJun 25, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THIS OCCURRED DURING PRIMING, NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610003 ↗
• MalfunctionSep 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456144 ↗
• MalfunctionSep 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456090 ↗
• MalfunctionSep 9, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT A CUSTOMER TRIED TO PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, BUT THE CUFF WOULD NOT INFLATE AND LEAKAGE OF AIR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392257 ↗
• MalfunctionSep 9, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT A CUSTOMER TRIED TO PUT AIR IN THE CUFF DURING THE PRE-USE CHECK, BUT THE CUFF WOULD NOT INFLATE AND LEAKAGE OF AIR WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15391893 ↗
• MalfunctionAug 26, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN INTUBATION FOR DENTAL SURGERY THE CUSTOMER HAD TO USE THREE (3) TUBES ON THE ONE PATIENT, EACH TIME THERE WERE LEAKS. THE BALLOON HAD ALWAYS BEEN CHECKED BEFOREHAND. THE LEAK CAME DIRECTLY FROM THE BLUE TUBE. THE CUSTOMER DID LEAK TESTS IN WATER TO SEE AND DISCOVERED A SMALL HOLE IN THE TUBE AND NOT IN THE BALLOON ON EACH ONE. THROAT EDEMA WAS ALSO NOTED FROM THE REPORTER. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Swelling/ Edema

  MAUDE report 15306428 ↗
• MalfunctionAug 26, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN INTUBATION FOR DENTAL SURGERY THE CUSTOMER HAD TO USE THREE (3) TUBES ON THE ONE PATIENT, EACH TIME THERE WERE LEAKS. THE BALLOON HAD ALWAYS BEEN CHECKED BEFOREHAND. THE LEAK CAME DIRECTLY FROM THE BLUE TUBE. THE CUSTOMER DID LEAK TESTS IN WATER TO SEE AND DISCOVERED A SMALL HOLE IN THE TUBE AND NOT IN THE BALLOON ON EACH ONE. THROAT EDEMA WAS ALSO NOTED FROM THE REPORTER. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Swelling/ Edema

  MAUDE report 15306357 ↗
• MalfunctionAug 26, 2022Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN INTUBATION FOR DENTAL SURGERY THE CUSTOMER HAD TO USE THREE (3) TUBES ON THE ONE PATIENT, EACH TIME THERE WERE LEAKS. THE BALLOON HAD ALWAYS BEEN CHECKED BEFOREHAND. THE LEAK CAME DIRECTLY FROM THE BLUE TUBE. THE CUSTOMER DID LEAK TESTS IN WATER TO SEE AND DISCOVERED A SMALL HOLE IN THE TUBE AND NOT IN THE BALLOON ON EACH ONE. THROAT EDEMA WAS ALSO NOTED FROM THE REPORTER. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Swelling/ Edema

  MAUDE report 15306240 ↗
• InjuryAug 4, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT (AN ENDOTRACHEAL TUBE), THE CUSTOMER NOTICED AIR WAS UNABLE TO BE PUT IN THE CUFF. SO HE REMOVED IT FROM THE PATIENT AND SUBMERGED IT IN WATER. AS A RESULT, AIR BUBBLES CAME OUT OF THE TUBE TIP. ALSO, WATER WENT INTO THE PILOT BALLOON. ADDITIONALLY IT WAS REPORTED THAT A NEW TUBE WAS CHOSEN AND PLACED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15166743 ↗
• MalfunctionJul 21, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077506 ↗
• MalfunctionJul 21, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS DETECTED. NO PATIENT INJURY OR ADVERSE AFFECTS. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15077483 ↗
• MalfunctionJul 15, 2022No Flow; No Flow

  IT WAS REPORTED THAT THE CUSTOMER PUT AIR IN THE CUFF, BUT IT WOULD NOT BE INFLATED. NO ANOMALY WAS FOUND IN THE PRE-USE CHECK. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15032912 ↗
• MalfunctionMay 27, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14523476 ↗
• MalfunctionMay 26, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515860 ↗
• MalfunctionMay 25, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, LEAKAGE OF AIR FROM THE CUFF WAS OBSERVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14497786 ↗
• MalfunctionApr 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER ATTEMPTED TO PUT AIR IN THE CUFF, BUT IT WOULD NOT BE INFLATED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14102451 ↗