Portex 100/870/060CZRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315104831), received between Sep 15, 2020 and Sep 16, 2020 — classified as 3 injuries.

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

• InjurySep 16, 2020Pressure Problem; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOTOMY CUFF WASN'T KEEPING AIR PRESSURE AFTER USING THE CUFF PRESSURE GAUGE. THERE WERE NO ADVERSE EVENTS REPORTED.

  Patient problems: No Information

  MAUDE report 10541433 ↗
• InjurySep 16, 2020Pressure Problem; Pressure Problem

  INVESTIGATION COMPLETED IN H 10.

  Patient problems: No Information

  MAUDE report 10541267 ↗
• InjurySep 15, 2020Pressure Problem; Pressure Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Information

  MAUDE report 10538375 ↗