Portex 100/136/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 15019315021312), received between Jul 2, 2018 and Jul 8, 2025 — classified as 5 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE PUMP HAD A CUFF LEAKAGE. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440476 ↗
• MalfunctionJan 11, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT "POOR CONDUCTION TO AIR IN THE INFLATION LINE WHEN INFLATING THE CUFF." THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18499140 ↗
• MalfunctionNov 15, 2022Device Damaged Prior to Use; Material Split, Cut or Torn; Device Damaged Prior to Use; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE NURSE FOUND THE BLUE INFLATION LINE WAS TORN AND DISLODGED FROM THE ENDOTRACHEAL TUBE WHILE OPENING BEFORE USE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15799237 ↗
• MalfunctionMar 13, 2021Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11478456 ↗
• MalfunctionJan 14, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE OPERATOR NOTICED THAT MEDICAL FLUID WAS LEAKING FROM THE PART WHERE THE INFLATION LINE AND THE TUBING CONNECT. THE LEAK OCCURRED BECAUSE OF A LOOSE CONNECTION. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11171117 ↗
• MalfunctionDec 13, 2020Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE CUSTOMER FOUND A PINHOLE IN THE BASE PART OF THE TUBE'S INFLATION LINE. NO PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 10999945 ↗
• InjuryJun 26, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE THE ANESTHETIC NOTICED THAT THE CIRCUIT HAD A 90ML LEAK. AT THE END OF THE PROCEDURE THE PATIENT WAS EXTUBATED WITHOUT ISSUE. UPON EXAMINATION IT WAS FOUND THAT THERE WAS A LEAK FROM THE POINT WHERE THE PILOT BALLOON TUBING ENTERS THE MAIN BODY OF THE ENDOTRACHEAL TUBE. THE SURGERY WAS COMPLETED UNEVENTFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737682 ↗
• InjuryJan 23, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE HAD A HOLE IN THE TUBING, LEADING TO A LEAKAGE WHERE THE INFLATION LINE IS MOLDED TO THE TUBE. AS A RESULT, AN ENDOTRACHEAL TUBE CHANGE OUT WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270156 ↗
• InjuryNov 20, 2018Output Problem; Output Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX ENDOTRACHEAL TUBE HAD A HOLE IN THE TUBE AND LEAKAGE OCCURRED WHERE THE INFLATION LINE IS MOLDED TO THE TUBE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8092566 ↗
• InjuryOct 5, 2018Gas/Air Leak; Gas/Air Leak

  AN ADULT PATIENT FOR TONSILLECTOMY WAS INTUBATED WITH A CUFFED RAE TYPE TUBE. THE PATIENT THEN HAD THE BOYLE DAVIS GAG APPLIED (STANDARD TONSILLECTOMY EQUIPMENT AND THE LEAK BECAME APPARENT. ANOTHER SIMILAR TUBE WAS SELECTED AND THE PATIENT WAS RE-INTUBATED WITH NO SEQUELAE. THERE WERE NO OMISSIONS IN CHECKING THE EQUIPMENT AS THE DEFECT WAS MINUTE AND THE LEAK ONLY BECAME APPARENT WHEN THE TUBE BECAME DISTORTED BY THE BOYLE DAVIS GAG.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7939481 ↗
• InjuryJul 2, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL ENDOTRACHEAL TUBE WAS REPORTED TO HAVE A PERSISTENT LEAK. REPORT OF HOLE IN TUBE. NO PATIENT INJURY RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7656436 ↗