AirLife™ 3215Recalls & reported problems

Vyaire Medical, Inc. · Isothermal Pediatric Omni - Flex Connector · Class 1

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10190752147690), received between Apr 19, 2024 and Apr 19, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Integrity 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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Material Integrity Problem1
Material Split, Cut or Torn1

Patient problems

Unspecified Respiratory Problem1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 19, 2024Material Integrity Problem; Material Split, Cut or Torn; Material Integrity Problem; Material Split, Cut or Torn
ONCE THE PLASTIC COLLAPSES, THE AIRFLOW TO MY PATIENT IS PARTIALLY OBSCURED. THE PLASTIC ALSO LOOKS LIKE IT WILL START TO SPLINTER AND OPEN, WHICH COULD POTENTIALLY CAUSE MY PATIENT TO INHALE PLASTIC SHARDS.
Patient problems: Unspecified Respiratory Problem
MAUDE report 19148747 ↗

Device details

UDI-DI	`10190752147690`
Brand	AirLife™
Model	3215
Company	Vyaire Medical, Inc.
Product code	BZA · CONNECTOR, AIRWAY (EXTENSION)
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 28, 2022

Device type (GMDN): Straight/elbow breathing circuit connector, single-use

A device intended to create a direct connection between a breathing circuit breathing tube and an endotracheal (ET) tube, anaesthesia face mask, or other non-sampling breathing circuit component. It is constructed with specific connecting dimensions and may be designed to connect breathing tubes from paediatric to adult sizes. It is typically made of plastic materials and can have a straight or elbow-shaped design (excludes Y-piece connectors). Some designs may allow for partial rotation at the point of connection (a swivel) and may include a suction port or gas sampling port. This is a single-use device.

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.