Portex 100/199/055Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315022296), received between Sep 4, 2022 and Jun 18, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INDIVIDUALLY WRAPPED PACKAGE CONTAINING THE TUBE SAYS 100/199/055, BUT THE PRINTING ON THE TUBE INSIDE SAYS 5MM. THIS OCCURRED AT THE TIME OF UNPACKING. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563491 ↗
• MalfunctionSep 6, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A BROWN STAIN WAS FOUND AT THE CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362676 ↗
• MalfunctionSep 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PRE-USE CHECK, THE USER NOTICED A PART OF THE INFLATION LINE WAS CAUGHT IN THE PACKAGE AND WAS DEFORMED. THE DEVICE WAS NOT USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15353969 ↗