Portex 100/189/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 15019315059537), received between May 14, 2018 and Jan 13, 2026 — classified as 21 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (19 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Leak/Splash

  IT WAS REPORTED THAT THE THAT THE CRITICAL CARE DOCTOR WAS USING IT, FOUND THAT THE TUBE WAS LEAKING AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24059755 ↗
• MalfunctionAug 12, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, DURING THE PROCESS OF OROTRACHEAL INTUBATION, IT WAS FOUND THAT THE AIR BAG WAS LEAKING. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22787376 ↗
• MalfunctionMay 5, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE WAS FOUND TO HAVE AN AIR LEAK WHEN THE BALLOON WAS PUMPED. THE DOCTOR REPLACED IT AND RE-PERFORMED THE ENDOTRACHEAL INTUBATION. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21965036 ↗
• MalfunctionApr 22, 2025Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT WHEN PREPARING THE INTUBATION TRAY FOR A PATIENT, THE NURSE WANTED TO TEST THE INTUBATION PROBE BY INFLATING THE BALLOON OF THE PROBE, THEY FOUND THAT THE BALLOON DID NOT INFLATE PROPERLY (LEAK) AND DEFLATED INSTANTLY. THERE IS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21882584 ↗
• MalfunctionMar 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE DISCOVERED A LEAK IN THE AIRBAG WHILE PRE-FILLING IT WITH SALINE, SO SHE PROMPTLY DISCARDED IT. THERE WAS NO PATIENT INVOLVEMENT, AND NO HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712738 ↗
• MalfunctionMar 17, 2025Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT SEEM TO INFLATE PROPERLY AND DEFLATE INSTANTLY. SHE THEN TOOK ANOTHER PROBE TO TEST IT AS WELL AND THE LAST ONE WAS NOT INFLATING AT ALL. PEC WAS DELAYED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21624968 ↗
• MalfunctionJun 18, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PILOT BALLOON DEFLATED WHILE DURING PATIENT REANIMATION. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: Insufficient Information

  MAUDE report 19561774 ↗
• MalfunctionApr 22, 2024Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160560 ↗
• MalfunctionApr 22, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT PRIOR TO PATIENT USE, WHEN IT CAME TO INFLATING IT, THE BALLOON STUCK TO THE TUBE. THE PROBLEM WAS REPORTED BEFORE USE ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19152779 ↗
• MalfunctionApr 2, 2024Gas/Air Leak; Unintended Deflation; Gas/Air Leak; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF WOULD NOT HOLD AIR. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19028646 ↗
• MalfunctionApr 2, 2024Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE CUFF WOULD NOT HOLD AIR. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 19027172 ↗
• MalfunctionJan 5, 2024Device Alarm System; Decrease in Pressure; Gas/Air Leak; Device Alarm System; Decrease in Pressure; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT HAD A VENTILATOR LOW TIDAL VOLUME ALARM AT 9:25. THE DOCTOR WAS INFORMED THAT THE AIR BAG PRESSURE WAS ESTIMATED TO BE 22CMH2O, AND IT WAS IMMEDIATELY INFLATED TO 32CMH2O. AFTER CALIBRATION, THE VENTILATOR LOW TIDAL VOLUME ALARM OCCURRED AGAIN AT 9:27. THE AIR BAG PRESSURE WAS 24CMH2O AND THE AIR BAG WAS SUSPECTED TO HAVE A LEAKAGE. THE ENDOTRACHEAL INTUBATION WAS REPLACED AT 9:30. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18451621 ↗
• MalfunctionNov 29, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT ON OCTOBER 28, 2023, THE PATIENT SUFFERED FROM GASTROINTESTINAL BLEEDING AND UNDERWENT EMERGENCY TRACHEAL INTUBATION TO PROTECT THE AIRWAY. BEFORE INTUBATION, THE DOCTOR CHECKED THE NO. 7.5 SUCTION TRACHEAL INTUBATION TUBE AND IMMERSED THE BALLOON IN STERILE SALINE WHICH HAD BUBBLES. THIS WAS TAKEN AS AN INDICATION OF LEAKING. THE AIRBAG WAS DISCARDED AND REPLACED WITH ANOTHER TRACHEAL INTUBATION TUBE. THERE WAS NO PATIENT ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232001 ↗
• InjuryNov 9, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE WAS TESTED PRIOR TO INTUBATING PATIENT FOR CUFF LEAKS AND PASSED. ONCE THE PATIENT WAS INTUBATED THE CUFF WOULD NOT HOLD AIR OR PRESSURE. THE PATIENT REQUIRED THIS TUBE TO BE REMOVED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107432 ↗
• InjuryNov 9, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE WAS TESTED PRIOR TO INTUBATING PATIENT FOR CUFF LEAKS AND PASSED. ONCE THE PATIENT WAS INTUBATED THE CUFF WOULD NOT HOLD AIR OR PRESSURE. THE PATIENT REQUIRED THIS TUBE TO BE REMOVED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. IT WAS REPORTED THAT NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107425 ↗
• InjuryNov 9, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT THE DEVICE WAS TESTED PRIOR TO INTUBATING PATIENT FOR CUFF LEAKS AND PASSED. ONCE THE PATIENT WAS INTUBATED THE CUFF WOULD NOT HOLD AIR OR PRESSURE. THE PATIENT REQUIRED THIS TUBE TO BE REMOVED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18107383 ↗
• InjuryApr 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A TUBE WAS IN USE ON A PATIENT AND A LEAKAGE OF THE CUFF WAS FOUND. THE TUBE WAS CHANGED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16733877 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK/DEFLATE UPON INTUBATION. NO INJURY. CUSTOMER CONFIRMED FOR THE QUANTITY AFFECTED: FIVE (5) TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16125205 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK/DEFLATE UPON INTUBATION. NO INJURY. CUSTOMER CONFIRMED FOR THE QUANTITY AFFECTED: FIVE (5) TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124729 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK/DEFLATE UPON INTUBATION. NO INJURY. CUSTOMER CONFIRMED FOR THE QUANTITY AFFECTED: FIVE (5) TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124522 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK/DEFLATE UPON INTUBATION. NO INJURY. CUSTOMER CONFIRMED FOR THE QUANTITY AFFECTED: FIVE (5) TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124480 ↗
• InjuryJan 9, 2023Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A CUFF LEAK/DEFLATE UPON INTUBATION. NO INJURY. CUSTOMER CONFIRMED FOR THE QUANTITY AFFECTED: FIVE (5) TRACHS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16124438 ↗
• InjuryAug 24, 2022Deflation Problem; Pressure Problem; Deflation Problem; Pressure Problem

  IT WAS REPORTED THAT THERE WAS CUFF DEFLATION AND MALFUNCTIONING OF A PRESSURE VALVE. VENTILATOR ASSOCIATED PNEUMONIA WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Pneumonia

  MAUDE report 15288169 ↗
• MalfunctionAug 4, 2022Disconnection; Fitting Problem; Disconnection; Fitting Problem

  IT WAS REPORTED THAT THE BLUE 15MM CONNECTOR KEPT DISCONNECTING FROM THE TRACHEAL TUBE. THE TIP WAS NOT DEEP ENOUGH INSIDE THE TUBE AND JUST DISCONNECTS. ISSUES OCCURRED UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15163312 ↗
• MalfunctionJul 26, 2022Disconnection; Disconnection

  IT WAS REPORTED THAT THE BLUE 15MM CONNECTOR KEPT DISCONNECTING FROM THE TRACHEAL TUBE. THE TIP WAS NOT DEEP ENOUGH INSIDE THE TUBE AND JUST DISCONNECTS. THE ISSUE OCCURRED UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15104017 ↗