Portex 22-4000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10788942240001), received between Aug 22, 2024 and Jan 9, 2025 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT, "UNABLE TO USE DUE TO AIR LEAKAGE." THE EVENT OCCURRED DURING INFUSION AT PATIENT'S HOME. THERE WAS A PATIENT INVOLVEMENT, BUT 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 21118460 ↗
• MalfunctionAug 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AIR LEAKED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20029328 ↗