Baxter Issues Urgent Medical Device Correction for Its Volara System

Baxter International issued an urgent medical device correction last week for its Volara home care system, calling on healthcare providers and users to monitor for signs of respiratory distress.

The Volara system can connect to a tracheostomy tube or deliver care via a mask, mouthpiece or inline ventilator. The company noted a possible risk of over-expansion and decreased oxygen levels that may result in lung tissue damage while using the Volara device in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit oscillation and lung expansion therapy.

Baxter said it has received one report of a patient experiencing oxygen desaturation while using the Volara device in line with a ventilator in a home care environment.

The company is updating its Instructions For Use manual to help ensure correct usage of the device. The Volara device is manufactured by Hillrom, which Baxter acquired in late 2021.