Portex 101/860/075CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 115 adverse event reports that list this exact device (DI 15019517076141), received between Aug 26, 2020 and Aug 11, 2026 — classified as 8 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (45 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 115 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Gas/Air Leak

  It was reported that an air leak occurred near the inflation line during patient use. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50208553 ↗
• MalfunctionMay 12, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAKED DURING PATIENT USE IN THE MIDDLE OF (B)(6) 2026. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25151265 ↗
• MalfunctionMay 4, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE AIR LEAKS FROM THE CUFF. PER REPORTER, THE EVENT OCCURRED DURING PATIENT USE. NO ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072328 ↗
• MalfunctionApr 14, 2026Crack

  IT WAS REPORTED THAT THERE WAS A CRACKED SUBGLOTTIC PORT. THE FAULT OCCURRED IN WARD WHERE THE PATIENT CURRENTLY IS WHILE IN USE WITH THE PATIENT. AN UNPLANNED TUBE CHANGE WAS REQUIRED, PATIENT VENTILATED AND DEPENDENT ON SGP SUCTION. THERE WAS PATIENT INVOLVEMENT AND NO ADVERSE HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24874407 ↗
• MalfunctionDec 16, 2025Break; Break

  IT WAS REPORTED THAT THE CUFF WAS BROKEN. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817435 ↗
• MalfunctionNov 10, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF DURING USE. NO PATIENT HARM OR ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23510829 ↗
• MalfunctionSep 17, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23076631 ↗
• MalfunctionSep 12, 2025Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PATIENT SUFFERED A CUFF RUPTURE AFTER INSERTION. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037561 ↗
• MalfunctionAug 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK FROM THE PILOT BALLOON DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22797841 ↗
• MalfunctionMay 1, 2025Suction Failure; Suction Failure

  IT WAS REPORTED THAT THE PHLEGM COULD NOT BE COUGHED UP. THE EVENT OCCURRED WHILE PATIENT USE AT THE FACILITY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942614 ↗
• MalfunctionMar 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE HAD AN AIR LEAK. THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583916 ↗
• MalfunctionNov 4, 2024Material Rupture; Gas/Air Leak; Material Rupture; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TRACHEOSTOMY FOR PNEUMONIA 4 YEARS PRIOR, AND THE PATIENT BREATHED THROUGH A TRACHEAL CANNULA AND WAS VENTILATED WITH ASSISTED VENTILATION. THE ENDOTRACHEAL CANNULA WAS REPLACED ON (B)(6) 2024, AND THEN VENTILATOR-ASSISTED VENTILATION WAS APPLIED WITH INTERMITTENT SUCTIONING. ON (B)(6) 2024, THE ENDOTRACHEAL CANNULA WAS FOUND TO BE RUPTURED, LEAKING, AND HYPO-VENTILATED, AND THE ENDOTRACHEAL CANNULA WAS IMMEDIATELY REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20599560 ↗
• MalfunctionOct 21, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT AFTER INTUBATION, THE CUFF DEFLATED AND WAS REPLACED. SOON AFTER REPLACEMENT THE CUFF DEFLATED, SO IT WAS REPLACED AGAIN. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494694 ↗
• MalfunctionOct 21, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT AFTER INTUBATION, THE CUFF DEFLATED AND WAS REPLACED. SOON AFTER REPLACEMENT THE CUFF DEFLATED, SO IT WAS REPLACED AGAIN. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20494419 ↗
• MalfunctionOct 10, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE CUFF WAS INFLATED BEFORE USE ON THE PATIENT, AIR LEAKED OUT OF THE CUFF, AND IT DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20418825 ↗
• MalfunctionSep 17, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE WAS SLIPPING DURING USE. THERE WAS A PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240900 ↗
• MalfunctionSep 17, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF PRESSURE WAS LOST DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240496 ↗
• MalfunctionAug 14, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE PILOT BALLOON FELL OUT. THIS OCCURRED DURING INFUSION AT THE FACILITY. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982990 ↗
• MalfunctionJul 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT "CHECKED FOR LEAK ABOUT 5H AFTER PATIENT USE. CHECKED AFTER EXTUBATION AND IT WAS CLEAR THAT AIR WAS ESCAPING." THERE WAS PATIENT INVOLVEMENT, BUT NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19776362 ↗
• MalfunctionJul 11, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WAS ATTEMPTED TO BE INFLATED AFTER TUBE INTUBATION, BUT THE CUFF DID NOT INFLATE. THIS OCCURRED DURING PATIENT USE, NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19724613 ↗
• MalfunctionJun 17, 2024Leak/Splash; Gas/Air Leak; Leak/Splash; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS INFLATED WITHOUT ANY PROBLEM IN THE PRE-USE CHECK, BUT A WHILE AFTER INTUBATING THE PATIENT, IT DEFLATED DUE TO AIR LEAKAGE, AIR WAS THEN INJECTED, BUT THE AIR LEAKED AGAIN. A NEW PRODUCT WAS RE-INTUBATED, AND THE PATIENT WAS ABLE TO USE THE CUFF WITHOUT ANY PROBLEMS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19546958 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED FROM THE CUFF. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19305043 ↗
• MalfunctionApr 22, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DIFFICULT TO INFLATE. THE SPRING ON THE PILOT BALLOON WAS NOT SEATED PROPERLY, MAKING IT DIFFICULT TO INSERT THE SYRINGE. THIS OCCURRED UPON OPENING THE PACKAGE/CARTON AT PATIENT'S HOME. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152988 ↗
• InjuryApr 5, 2024Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT "EIGHT DAYS AFTER PLACEMENT, THE CUFF WAS LOSING AIR. AFTER REPLACEMENT, THE AFFECTED CUFF WAS FILLED WITH AIR AND LEFT IN PLACE FOR SIX (6) HOURS, AND AIR WAS SLOWLY BEING RELEASED". THIS OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052261 ↗
• MalfunctionMar 19, 2024No Pressure; No Pressure

  IT WAS REPORTED THAT THE USER "CONFIRMED THE CUFF PRESSURE OF THE PILOT BALLOON AND IT WAS 0". THE EVENT OCCURRED IN EARLY FEB-2023, EXACT DATE UNKNOWN. THIS OCCURRED DURING PATIENT USE, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18935433 ↗