The FDA issued a notice today labeling the recall of the Baxter (NYSE:BAX) Volara lung therapy system as Class I, the most serious kind.
Earlier this month, Baxter announced that it issued an urgent medical device correction for its Volara system for oscillation and lung expansion (OLE) therapy. To date, there has been one complaint and one injury, as well as two deaths associated with the use of the device.
Baxter initiated the recall on April 26, 2022. It affects devices distributed between May 28, 2020, and April 19, 2022, totaling 268 devices recalled in the U.S.
Volara, manufactured by Hillrom, which Baxter acquired for $12.5 billion last year, presents a possible risk of the decrease in oxygen levels (oxygen desaturation) that may result in lung tissue damage due to over-expansion (barotrauma) in the home care environment. Such events may occur while using Volara in line with a ventilator with the required Volara ventilator adaptor or Volara patient circuit kit OLE therapy.
According to the FDA notice, risks to affected patients include choking on mucus or other airway secretions, an infection in the lungs (pneumonia) that prevents oxygen from getting to the blood (respiratory failure), brain injury caused by lack of oxygen to the brain (hypoxia) and/or death.
FDA said the risk of serious injury or death is more significant in home-care settings if caregivers are not trained properly, the device is not connected properly or if the caregiver is not prepared to address any issues that may arise caused by the use of the device.
Baxter instructed current patients to continue to use Volara therapy as prescribed by their physician, while caregivers and/or patients should monitor for signs of respiratory distress during Volara therapy when used in line with a ventilator.
The company plans to mitigate the risk associated with Volara by updating the instructions for use manual to ensure the correct usage of the device. Baxter intends to contact patients to arrange for a trainer to conduct a home visit to provide additional training and to issue a follow-up letter to patients to communicate further details on the actions being taken to address the issue.