Portex Z210-16Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315046919), received between Feb 10, 2021 and Feb 10, 2021 — classified as 2 injuries.

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. How this data works · Data updated Oct 13, 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.

• InjuryFeb 10, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE PORTEX CATHETERS SUCTION PRO LEAKED. WHEN INSTALLING THE CLOSED SUCTION SYSTEM IN THE TUBE AFTER INTUBATION, IN THE PART OF THE CLOSED SUCTION PROBE, THERE WAS A NOISE THAT APPEARED TO LEAK. THE CHANGE TO A NEW CLOSED SUCTION SYSTEM WAS CARRIED OUT. PRODUCT WAS DISCARDED DUE TO CONTAMINATION COVID 19.

  Patient problems: Ventilator Dependent

  MAUDE report 11310564 ↗
• InjuryFeb 10, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION WAS RECEIVED INDICATING THAT THE PORTEX CATHETERS SUCTION PRO LEAKED. IT WAS NOT POSSIBLE TO IDENTIFY THE LOCATION OF THE LEAK, BUT AN AUDIBLE LEAK WAS NOTED. THE CONSEQUENCES WAS DEPRESSURIZATION WITH A HIGH PEEP IN A PROTONATED PATIENT.

  Patient problems: Ventilator Dependent

  MAUDE report 11310094 ↗