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 ve…