Portex 100/199/065Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 15019315022319), received between Apr 12, 2020 and Sep 24, 2026 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (7 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50889232 ↗
• MalfunctionSep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591696 ↗
• MalfunctionSep 3, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50591672 ↗
• MalfunctionDec 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAK FROM THE WELDED JOINT BETWEEN THE CUFF AND THE UPPER TUBE. THE EVENT OCCURRED DURING PATIENT USE, AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687069 ↗
• MalfunctionMay 20, 2025Contamination; Contamination

  IT WAS REPORTED THAT THERE WERE BLACK SPOTS ON THE CUFF. THE EVENT OCCURRED DURING PRIMING. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049462 ↗
• MalfunctionJan 15, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "THE CUFF WAS DIFFICULT TO INFLATE." THE EVENT OCCURRED WHEN OPENING. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21158322 ↗
• MalfunctionJan 9, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT "PILOT BALLOON DEFLATES DURING PATIENT USE". THIS OCCURRED DURING PATIENT USE, NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21118159 ↗
• MalfunctionOct 9, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF LEAK OCCURRED DURING USE IN THE PATIENT. THIS OCCURRED DURING PATIENT USE AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409162 ↗
• MalfunctionJun 10, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THERE WAS A MALFUNCTION OF THE CUFF INFLATION PRESSURE VALVE. THE VALVE BECAME PRESSURIZED BUT THE INTRATRACHEAL CUFF DID NOT INFLATE. THERE WAS SUSPICION OF A SIMILAR EVENT FOR ANOTHER PATIENT WHO ALSO HAD TO BE RE-INTUBATED WHILE THE CUFF WAS PUNCTURED. THE EVENT OCCURRED DURING PATIENT USE AND THAT THERE WERE NO CLINICAL CONSEQUENCES, BECAUSE THE PATIENT WAS RE-INTUBATED. HE WAS NOT PRESCRIBED ANY MEDICAL TREATMENT AND THE EVENT STATUS IS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19506094 ↗
• MalfunctionApr 29, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEADLINE IS UNCLEAR AND CANNOT BE READ. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19202757 ↗
• MalfunctionJun 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED, THAT THERE WAS AN AIR LEAK. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17043182 ↗
• MalfunctionMay 4, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND LEAKING AFTER INTUBATION. NO PATIENT HARM REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16869477 ↗
• MalfunctionApr 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A WHITE LOOKING POWDER FOUND ON THE BALLOON CUFF OF THE TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16817028 ↗
• InjuryMar 13, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT HAD MULTIPLE INJURIES WHICH INCLUDED A PELVIC FRACTURE (WEST), HEMORRHAGIC SHOCK, TRAUMATIC SPLENIC RUPTURE, RIB FRACTURE (WESTERN) EMERGENCY DEPARTMENT FOR TOTAL SPLENECTOMY AND ARTERIAL EMBOLIZATION. AN ENDOTRACHEAL INTUBATION WAS PERFORMED OCTOBER 30TH, WITH VENTILATOR ASSISTED BREATHING, AND A POSTOPERATIVE TRANSFER TO THE ICU. ENDOTRACHEAL TUBE FIXED AND MANAGED SMOOTHLY, AIR BAG PRESSURE WAS NORMAL, THE PATIENT WAS OCCASIONALLY AGITATED, AND SEDATIVES CONTINUED TO BE USED. WHEN THE PATIENT'S BALLOON PRESSURE WAS MEASURED THE AFTERNOON OF NOVEMBER 2ND, THE AIRBAG PRESSURE OF THE PATIENT WAS MEASURED, AND ABNORMALITIES WERE FOUND, AND THE VENTILATOR ALARMED ABNORMALLY. THE PATIENT COUGHED VIOLENTLY, AND THE VOICE IN THE THROAT WAS ABNORMAL. IMMEDIATELY CHECKED THE PERFORMANCE OF THE ENDOTRACHEAL TUBE AND ENDOTRACHEAL RE-INTUBATION WAS PERFORMED.

  Patient problems: Respiratory Insufficiency

  MAUDE report 16533206 ↗
• MalfunctionMar 3, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE PRODUCT GOT DEFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482864 ↗
• MalfunctionJan 13, 2023Noise, Audible; Noise, Audible

  IT WAS REPORTED THAT WHEN THE CUSTOMER WAS PUTTING AIR IN THE CUFF, A STRANGE NOISE WAS HEARD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163533 ↗
• MalfunctionOct 1, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED THE CUFF WOULD NOT BE INFLATED. SO HE CHANGED IT TO ANOTHER ONE. AFTER THE MEDICAL OPERATION, THE CUSTOMER CHECKED THE COMPLAINT PRODUCT AGAIN, BUT THIS TIME, IT WAS SUCCESSFULLY INFLATED. SO HE SUSPECTED THERE HAD BEEN A TEMPORARY ANOMALY IN IT. NO PATIENT INJURY. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15522366 ↗
• MalfunctionSep 7, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE NURSE FOUND A CUFF LEAK DURING TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15368924 ↗
• MalfunctionSep 6, 2022Structural Problem; Structural Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER ATTEMPTED TO INFLATE THE CUFF, BUT COULD NOT DO IT WELL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362679 ↗
• MalfunctionApr 21, 2022Deflation Problem; Inflation Problem; Deflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DIFFICULT TO INFLATE AND DEFLATE. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14166729 ↗
• InjuryApr 12, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING AFTER 10 MINUTES IN 2 UNITS OF THE PRODUCTS. THE DEVICE HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090202 ↗
• InjuryApr 12, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS LEAKING AFTER 10 MINUTES IN 2 UNITS OF THE PRODUCTS. THE DEVICE HAD TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14090156 ↗
• MalfunctionJan 3, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE PILOT BALLOON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142742 ↗
• MalfunctionNov 14, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT LEAKAGE OF AIR FROM THE PRODUCT WAS FREQUENTLY OBSERVED DURING THE USE OF IT IN AN OPERATION. SO THE CUSTOMER REMOVE IT FROM THE PATIENT AND CHECKED FOR LEAKAGE BY SUBMERGING IT IN WATER. AS A RESULT, AIR LEAK WAS DETECTED. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12808338 ↗
• MalfunctionOct 2, 2020Inflation Problem; Detachment of Device or Device Component; Inflation Problem; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED INDICATING THAT FOUR DAYS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE, THE CUFF WAS NOTED TO BE DEFLATED. IT WAS REPORTED THAT THE INFLATION LINE HAD BECOME DETACHED FROM THE TUBE WHERE IT HAD BEEN BONDED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10621368 ↗