AirLife and Vyaire are recalling certain Infant Heated Wire Circuits due to risk for inadvertent adapter disconnection during ventilation, according to the FDA.
AirLife and legal manufacturer Vyaire sent all affected customers an Urgent Medical Device Recall letter for certain Infant Heated Wire Circuits due to the risk that accessory adapters provided with the product may unintentionally disconnect during setup or use when the circuit reaches operating temperature, according to an FDA advisory.
AirLife Infant Heated Wire Circuits are used during ventilation support to warm breathing gases before they enter a patient’s airway. They are used in neonatal and infant patients and function as a conduit for respiratory gas between the patient and a ventilator.
The FDA says use of the affected product may cause serious adverse health consequences, including lack of oxygen to the body (hypoxia), carbon dioxide build-up in the blood (hypercapnia), organ failure and death.
No serious injuries and no deaths associated with this issue have been reported, the FDA says.
FDA Recommendations:
- Do not use affected devices with the adapter connections from the accessory bag of the AirLife Infant Heated Wire Circuit.
- Immediately stop using any devices that are connected using these adapters.
- If the adapter connection is not being used with the device, you may continue to use it.
On April 10, 2025, AirLife and legal manufacturer Vyaire sent all affected customers an Urgent Medical Device Recall letter recommending the following actions:
- Examine inventory for affected lots.
- Quarantine all affected product.
- Make sure all affected personnel are aware of this recall notification.
- For in-use products:
- Stop use of affected product if adapter connections are used in the circuit.
- Continue using affected product if the adapter connections are NOT being used with the device.
- Perform frequent checks on ventilator settings, tubing, and connections to ensure they are firmly tight, secure, and functioning properly.
- Make sure all alarms for pressure, flow, and disconnection are activated and monitor the patient’s respiratory parameters closely.
- Keep backup ventilation and/or manual resuscitation devices should be available at the bedside for emergent situations.
- Monitor oxygen saturation (Sp02), heart rate, and respiratory rate to make sure clinicians are alerted to any adverse event.
- Before use:
- Test the circuit by blocking the patient connection port and pressure testing it to ensure that there are no leaks.
- Complete and return the Response Form attached to the letter.
- Notify any customers/consignees who may have received affected product.
- Call AirLife directly at 1-800-433-2797 if replacement products are needed urgently.
