Portex 100/133/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 15019315020346), received between Nov 10, 2017 and Aug 7, 2026 — classified as 17 injuries, 66 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (25 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 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2026Fluid/Blood Leak

  It was reported that during patient use, inflatable cuff on the Endotracheal (ET) Tube was not holding and maintaining cuff pressure. The ET Tube was checked prior to the intubation and held 30mmgh without issues and also passed the vacuum test also. The cuff was therefore perforated and was unable to maintain sealing pressure. There was patient involvement and no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50182106 ↗
• MalfunctionJul 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50075237 ↗
• MalfunctionJul 29, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074543 ↗
• MalfunctionFeb 3, 2026Air/Gas in Device

  IT WAS REPORTED THAT TWO CASES OF CUFF AIR LEAK OCCURRED CONSECUTIVELY DURING THE OPERATION. THERE WAS A POSSIBILITY OF A HOLE. ALTHOUGH A CUFF AIR CHECK WAS PERFORMED BEFORE INTUBATION, THE ISSUE OCCURRED IN THE SAME LOT. (ONE OF THE TWO TUBES HAD BEEN DISCARDED.) THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247814 ↗
• MalfunctionFeb 3, 2026Material Split, Cut or Torn; Air/Gas in Device

  IT WAS REPORTED THAT TWO CASES OF CUFF AIR LEAK OCCURRED CONSECUTIVELY DURING THE OPERATION. THERE WAS A POSSIBILITY OF A HOLE. ALTHOUGH A CUFF AIR CHECK WAS PERFORMED BEFORE INTUBATION, THE ISSUE OCCURRED IN THE SAME LOT. (ONE OF THE TWO TUBES HAD BEEN DISCARDED.) THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247810 ↗
• MalfunctionNov 19, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT, ON THREE INSTANCES, THE BALLOON HAS DEFLATED ON ITS OWN. IT WAS CHECKED BEFORE USE WITH NO ISSUES FOUND. THE PATIENT WAS UNDER ANESTHETIC AND HAD NOT BEEN AFFECTED MEDICALLY. THE PROCEDURE WAS COMPLETED WITH A NOTED DELAY. A DIFFERENT PRODUCT LOT WAS USED INSTEAD. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597418 ↗
• MalfunctionJun 13, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A CUFF LEAK DUE TO A SMALL HOLE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE UNKNOW PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202622 ↗
• InjuryMay 23, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THE CUFF WAS INFLATED AND THEN IMMEDIATELY DEFLATED WHICH RESULTED IN THE PATIENT HAVING TO BE EXTUBATED AND RE-INTUBATED FOR UP TO THREE TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22075846 ↗
• MalfunctionMay 15, 2025Inflation Problem; Leak/Splash; Tear, Rip or Hole in Device Packaging; Inflation Problem; Leak/Splash; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS CHECKED FOR AIR LEAKAGE AFTER INSERTION, AND IT WAS FOUND THAT THERE WAS A AIR LEAK. ALTHOUGH THERE WAS NO LEAKAGE DURING CUFF CHECK BEFORE INSERTION. THE EVENT OCCURRED DURING PATIENT USE/DOSE, AND THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22026501 ↗
• MalfunctionMar 3, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A CUFF LEAK DUE TO A SMALL HOLE. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED. THERE WERE UNKNOW PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21510636 ↗
• MalfunctionJan 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THERE WERE NO PROBLEMS WHEN CHECKING THE CUFF BEFORE USE ON THE PATIENT, BUT WHEN THEY PLACED IT ON THE PATIENT AND TRIED TO INFLATE IT WITH AIR, THE SAME ISSUE OCCURRED TWO TIMES IN A ROW, AND THE THIRD CUFF BARELY MANAGED TO GET AIR IN, SO WE CONTINUED USING IT." THIS OCCURRED DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21081869 ↗
• MalfunctionJun 4, 2024Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATED DURING THE PRE-USE INSPECTION. THE OPERATOR OF THE DEVICE WAS A HEALTH PROFESSIONAL AND THE EVENT OCCURRED IN THE HOSPITAL. THIS OCCURRED DURING PRIMING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19459465 ↗
• MalfunctionMay 13, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT A CUFF LEAK OCCURRED. THIS OCCURRED DURING PATIENT USE AT THE FACILITY. THERE WAS A PATIENT INVOLVEMENT AND NO HARM/ADVERSE EVENT REPORTED. THERE WAS NO DISINFECTION OR STERILIZATION, AND NO INFECTIOUS DISEASE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19306231 ↗
• MalfunctionMay 13, 2024Deflation Problem; Gas/Air Leak; Deflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A POST-INTUBATION PROBLEM WITH THE CUFF DEFLATING ON TWO CONSECUTIVE PROBES WITH TWO DIFFERENT SIZES (6 AND 6.5)". THERE WAS A PATIENT INVOLVED, AND THE CONSEQUENCES OF THE EVENT WERE BLEEDING.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19300414 ↗
• MalfunctionMar 7, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WAS PUNCTURED EVEN BEFORE BEING USED. THE MALFUNCTION WAS IDENTIFIED IN THE PRE-USE TEST BEFORE PLACEMENT BY THE DOCTOR. THERE IS A SAMPLE AVAILABLE FOR EVALUATION. THERE WAS NO PATIENT INVOLVEMENT, HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18861453 ↗
• InjuryFeb 21, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT DURING AN ELECTIVE SURGERY, MATERIAL CHECKED, WHEN THE ENDOTRACHEAL TUBE WAS PASSED WITH A BALLOON IN THE NORTH OF THE NOSE, A HOLE WAS NOTICED, REQUIRING REPLACEMENT. IT WAS UNKNOWN IF THERE WAS ANY INJURY OR ADVERSE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 18747800 ↗
• MalfunctionFeb 16, 2024Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE BALLOON WAS PUNCTURED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18726988 ↗
• MalfunctionJan 11, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS AN AIR LEAK. "CHECKED FOR AIR LEAKS AFTER INSERTION. AFTER EXTUBATION, CHECKED THE CUFF AREA AND CONFIRMED LEAKS". NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498466 ↗
• MalfunctionNov 15, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING MANIPULATION THE TUBE BECAME PIERCED OR PUNCTURED. THIS CAUSED THE BALLOON TO NON-INFLATE. PATIENT INVOLVEMENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18142260 ↗
• MalfunctionNov 15, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING MANIPULATION THE TUBE BECAME PIERCED OR PUNCTURED. THIS CAUSED THE BALLOON TO NON-INFLATE. PATIENT INVOLVEMENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18142254 ↗
• MalfunctionNov 15, 2023Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  IT WAS REPORTED THAT DURING MANIPULATION THE TUBE BECAME PIERCED OR PUNCTURED. THIS CAUSED THE BALLOON TO NON-INFLATE. PATIENT INVOLVEMENT IS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18142252 ↗
• MalfunctionOct 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PATIENT USE IT WAS NOTICED THE CUFF WOULD NOT INFLATE. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18007193 ↗
• InjuryJul 31, 2023Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED BY HEALTHCARE PERSONNEL THAT THEY HAD A FAULTY VALVE ON A TRACHEAL TUBE. THE CUFF WOULDN'T HOLD THE INFLATION PRESSURE ONCE INSERTED. NO INJURY OR ADVERSE EFFECTS REPORTED. THE TUBE WAS EXCHANGED USING A CATHETER. THE FAULT WAS DISCOVERED BY THE ANESTHETIST AFTER THE PRODUCT WAS EXCHANGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17430798 ↗
• MalfunctionJul 21, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN UN-USED TRACH TUBE WAS FOUND TO HAVE FAULT PRIOR TO PLACEMENT. WHEN THE ETT WAS CONNECTED TO VENTILATION CIRCUIT, CUFF STARTED TO LEAK. EXTUBATED THE PATIENT AND INTUBATED WITH NEW (CHECKED) ETT AND KEPT THE CUFF PRESSURE GAUGE ATTACHED TO THE TUBE THROUGHOUT OPERATION. WHEN CUFF PRESSURE GAUGE WAS REMOVED THE CUFF STARTED TO LEAK AND IT DIDN'T HELP TO FILL CUFF MANUALLY WITH SYRINGE. PATIENT WAS EXTUBATED. NO VISIBLE FAULTS WERE DETECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THREE COMPLAINTS REPRESENT THE SAME PATIENT; (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17370797 ↗
• InjuryJul 12, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT WHEN THE ETT WAS CONNECTED TO VENTILATION CIRCUIT, CUFF STARTED TO LEAK. EXTUBATED THE PATIENT AND INTUBATED WITH NEW (CHECKED) ETT AND KEPT THE CUFF PRESSURE GAUGE ATTACHED TO THE TUBE THROUGHOUT OPERATION. WHEN CUFF PRESSURE GAUGE WAS REMOVED THE CUFF STARTED TO LEAK AND IT DIDN'T HELP TO FILL CUFF MANUALLY WITH SYRINGE. PATIENT WAS EXTUBATED. NO VISIBLE FAULTS WERE DETECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THREE COMPLAINTS REPRESENT THE SAME PATIENT; (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17309663 ↗