Portex 101/860/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517077919), received between Nov 30, 2023 and Apr 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SUCTION PORT CAME OFF WHILE THE SUCTION PORT WAS BEING CONNECTED TO THE SUCTION CONNECTOR TUBE. THE FAULT PRESUMABLY OCCURRED DURING SUCTION WHILE IN PATIENT USE. NO PATIENT INJURY OR CLINICAL AFFECTS WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767724 ↗
• MalfunctionApr 2, 2026Disconnection

  IT WAS REPORTED THAT THE SUCTION PORT CAME OFF WHILE THE SUCTION PORT WAS BEING CONNECTED TO THE SUCTION CONNECTOR TUBE. THE EVENT OCCURRED IN A HOSPITAL AND WAS OPERATED BY A HEALTH PROFESSIONAL. THE FAULTY OCCURRED FOUND PRESUMABLY OCCURRED DURING SUCTION AFTER APPLYING THE PRODUCT TO THE PATIENT. THERE WERE PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766364 ↗
• MalfunctionJan 28, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT WATER ACCUMULATED IN THE PILOT BALLOON. THE EVENT OCCURRED DURING THE PATIENT USE. THERE WAS NO ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24203679 ↗
• MalfunctionAug 1, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE AIR LEAKS FROM THE PILOT BALLOON WITHIN 2-3 DAYS AND IT FALLS OFF. THE REPORTER STATED WHEN THE CUSTOMER CHECKED THE CAUSE ON-SITE BY PLACING IT IN WATER, THEY FOUND THAT THE AIR WAS LEAKING FROM THE AIR INLET. THE EVENT OCCURRED DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22687793 ↗
• MalfunctionNov 30, 2023Gas/Air Leak; No Pressure; Gas/Air Leak; No Pressure

  IT WAS REPORTED THAT DURING PATIENT USE, THERE WAS CUFF AIR LEAKAGE. AIR LEAKING FROM THE PILOT BALLOON CONNECTION, NO PRESSURE FELT IN THE PILOT BALLOON AFTER ABOUT FORTY (40) MINUTES. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18240898 ↗