Portex 100/189/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 15019315059520), received between Jul 3, 2018 and Sep 10, 2025 — classified as 1 death, 22 injuries, 34 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 10, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT THE AIRBAG WAS LEAKING, AND THE TUBE WAS DISCOVERED BROKEN WHILE INTUBATING THE PATIENT. THERE WAS NO PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23017104 ↗
• MalfunctionMay 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "BEFORE INTUBATION, PUT AIR IN THE CUFF AND CHECK THAT IT SWELLS. AFTER INTUBATION, EVEN IF THE OPERATOR PUT AIR IN THE CUFF, IT DID NOT GO IN." THERE WERE NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22020541 ↗
• MalfunctionMay 1, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE 43-YEAR-OLD-FEMALE PATIENT WAS ADMITTED TO THE OPERATING ROOM. THE ELECTROCARDIOGRAM (ECG) MONITORING SHOWED THAT THE SUCTION ENDOTRACHEAL TUBE WAS NORMAL AT 7.0. AFTER THE INDUCTION INTUBATION, THE PATIENT HELD THEIR BREATH IMMEDIATELY AFTER THE BALLOON WAS INFLATED. THE PATIENT ALSO HELD THEIR BREATH AFTER MULTIPLE INFLATIONS. THEY THEN HAD TO REPLACE THE NEW SUCTION ENDOTRACHEAL TUBE AND INTUBATE AGAIN. THE DAMAGED ENDOTRACHEAL TUBE WAS REMOVED AND IMMERSED IN WATER BEFORE INFLATING. IT WAS FOUND THAT THERE WAS A LEAK AT THE JUNCTION OF THE BALLOON EXTENSION TUBE AND THE ENDOTRACHEAL ARM. NO SUBSTANTIAL HARM WAS CAUSED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942687 ↗
• InjuryApr 4, 2025Material Twisted/Bent; Suction Failure; Material Twisted/Bent; Suction Failure

  IT WAS REPORTED THAT THE PATIENT WAS LATER TRANSFERRED TO LUND FOR CONTINUED CARE ON A RESPIRATOR AFTER BEING INTUBATED. IT WAS NOT POSSIBLE FOR THE HEALTHCARE PROVIDER TO SUCTION THE TUBE PROPERLY. UPON INSPECTION WITH A BRONCHOSCOPE, A KINK ON THE TUBE WAS DISCOVERED THAT COULD NOT BE STRAIGHTENED OUT. NO PATIENT HARM OCCURRED, BUT THE PATIENT NEEDED A TUBE CHANGE WHICH WAS A POTENTIALLY CONCERNED MEDICAL INTERVENTION.

  Patient problems: Hypoventilation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775361 ↗
• InjuryNov 20, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT "DURING EXTUBATION OF A PATIENT IN THE ICU, THE TUBE GOT STUCK AND COULD NOT BE PULLED OUT. THE ATTEMPT WAS PAUSED UNTIL THE NEXT DAY AND DECONGESTIVE TREATMENTS WERE ADMINISTRATED. THE FOLLOWING DAY, DURING A SUCCESSFUL EXTUBATION, IT WAS OBSERVED THAT THE CUFF IN THE TUBE HAD SETTLED LIKE A FUNCTIONAL COLLAR AND THEREFORE COULD NOT BE PULLED OUT. WITH SOME FURTHER ADJUSTMENT, THE RESISTANCE FELT LESSENED, AND THE TUBE WAS REMOVED AND REPLACED OVER A GUIDEWIRE WITH A TUBE SIZE 6. AFTER 3 HOURS, THE PATIENT WAS EXTUBATED WITHOUT COMPLICATIONS. UPON INSPECTION OF TUBE SIZE 7, A CONE-SHAPED COLLAR WAS OBSERVED THAT CREATED RELATIVELY HIGH RESISTANCE TO EXTUBATION AS IT HOOKED UNDER THE VOCAL CORDS. THE PATIENT BECAME SIGNIFICANTLY HOARSE AND HAD TO SPEND AN UNNECESSARY EXTRA DAY ON THE VENTILATOR. IT IS UNKNOWN WHETHER THE PATIENT HAS SUSTAINED PERMANENT DAMAGE REQUIRING FOLLOW-UP WITH ENT".

  Patient problems: No Clinical Signs, Symptoms or Conditions; Sore Throat

  MAUDE report 20739444 ↗
• MalfunctionNov 13, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT "THERE WAS AN 8MM IN A BOX OF 7MM. THE LABEL STICKER SAYS 7MM BUT THE TUBE IS 8MM. THE DATE OF EVENT WAS 23-OCT-2024. THE SAMPLE WAS AVAILABLE FOR INVESTIGATION. THIS OCCURRED WHEN OPENING AT THE FACILITY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674990 ↗
• MalfunctionSep 4, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE CUFF BECAME STIFF WHEN THE PATIENT WAS TAKEN OUT AFTER INTUBATION THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20136620 ↗
• MalfunctionMay 23, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DOCTOR PERFORMED A BALLOON INFLATOR TEST BEFORE PERFORMING ENDOTRACHEAL INTUBATION. AFTER INFLATING, THE BALLOON QUICKLY LEAKED, MAKING IT UNUSABLE AND DISCARDED. HE IMMEDIATELY STOPPED USING IT AND REPLACED IT WITH A NEW SET, WHICH WORKED NORMALLY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19380720 ↗
• InjuryJan 26, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AFTER VISUAL INSPECTION, THE CUFF WAS INFLATED AND VISUALLY CHECKED FOR LEAKS. AFTER INSERTION, IT WAS NOTED THAT THE PATIENT'S PARAMETERS WERE NOT GOOD. A NEW ENDOTRACHEAL TUBE WAS USED FROM THE SAME LOT. AFTER THE FAILURE OF 3 CUFFS, AN 8MM ENDOTRACHEAL TUBE ONE SIZE LARGER WAS TESTED. THIS SHOWED NO AIR LEAK AND WAS EVENTUALLY PLACED ON THE PATIENT. THE PATIENT WAS INTUBATED SEVERAL TIMES. THERE WAS NO REPORT OF PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18586273 ↗
• MalfunctionJan 25, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT TESTING WAS MADE 2 TIMES USING A CUFF MANOMETER AND AIR LEAK WAS NOTICED. THESE LAST TESTS WERE PERFORMED BEFORE INTUBATION. THE INCIDENT WAS REPORTED TO FAGG. THE DEVICE WAS OPERATED BY A HEALTH PROFESSIONAL. THE DEVICE IS AVAILABLE FOR INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581348 ↗
• MalfunctionJan 25, 2024Break; Break

  IT WAS REPORTED THAT TWO ENDOTRACHEAL TUBES FROM THE SAME LOT WERE TESTED IN A QUIET SETTING AND THE CUFF "WENT OFF". THERE WAS NO PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18579435 ↗
• MalfunctionDec 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE EVENT OCCURRED IN (B)(6) 2023. THIS OCCURRED DURING PATIENT USE. NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18366000 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE NURSE WAS DISASSEMBLING THE SUCTION ENDOTRACHEAL TUBE, THE CONNECTOR CAME LOOSE AND FELL TO THE GROUND. THE NURSE IMMEDIATELY REPLACED IT WITH A NEW CONSUMABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187681 ↗
• MalfunctionJul 12, 2023Partial Blockage; Defective Component; Partial Blockage; Defective Component

  IT WAS REPORTED THAT UPON TESTING CUFF PRIOR TO INTUBATION, THERE WERE TINY BUBBLES WITHIN SOFT-SEAL CUFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313451 ↗
• MalfunctionJun 26, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED, THAT THE ENDOTRACHEAL TUBE HAS SOME EXTERNAL MATERIAL STICKING TO THE TUBE. IT WAS OBSERVED, AT THE TIME OF INSERTION. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, OR NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17199115 ↗
• MalfunctionAug 24, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE TUBE WAS CHECKED AND AN AIR LEAK WAS FOUND IN THE AIRBAG. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15289618 ↗
• 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 15288349 ↗
• MalfunctionAug 5, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WHO WAS INTUBATED HAD TO BE EXTUBATED AND RE-INTUBATED WITH A NON SACCET ET TUBE. THE ET TUBE HAD TO BE REPLACED DUE TO CUFF FAILURE. THERE WAS NO PATIENT INJURY REPORTED. THREE DEVICES IN TOTAL WERE USED ON THE SAME PATIENT ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15177131 ↗
• MalfunctionAug 5, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WHO WAS INTUBATED HAD TO BE EXTUBATED AND RE-INTUBATED WITH A NON SACCET ET TUBE. THE ET TUBE HAD TO BE REPLACED DUE TO CUFF FAILURE. THERE WAS NO PATIENT INJURY REPORTED. THREE DEVICES IN TOTAL WERE USED ON THE SAME PATIENT ON THE SAME DAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15176200 ↗
• 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 15163254 ↗
• MalfunctionAug 2, 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. NO CLINICAL CONSEQUENCE, ISSUE OCCURRED UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153758 ↗
• 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 14761093 ↗
• 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 14760516 ↗
• MalfunctionApr 11, 2022Gas/Air Leak; Gas/Air Leak

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14075417 ↗
• InjuryFeb 10, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WHO WAS INTUBATED HAD TO BE EXTUBATED AND RE-INTUBATED WITH A NON SACCET ET TUBE. THE ET TUBE HAD TO BE REPLACED DUE TO CUFF FAILURE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Airway Obstruction; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13508211 ↗