Devices that use auto servo ventilation/Adaptive Servo-Ventilation therapy - multiple brands

Increased risk of death for patients with symptomatic chronic heart failure

17 June 2015

Consumers and health professionals are advised that multiple devices which use auto servo ventilation/Adaptive Servo-Ventilation (ASV) therapy have been subject to recall actions due to an increased risk of death for patients with symptomatic chronic heart failure.

Devices that use ASV therapy are non-invasive flow generators (using a mask or similar device) that assist patients with various respiratory disorders. These devices are primarily used to treat central sleep apnoea in the patient's home.

Central sleep apnoea is a disorder in which a person's breathing repeatedly stops and starts during sleep. It occurs because the person's brain doesn't send proper signals to the muscles that control breathing. This condition is different from the more common obstructive sleep apnoea, in which you can't breathe normally because of upper airway obstruction.

The TGA has published safety alerts relating to recalls undertaken for the following products:

Click on the above links for further information relating to this issue and these devices.