Amid continued recall concerns, devices from Medtronic and Baxter were recently assigned the most serious recall type be the FDA.
In back-to-back announcements Thursday, the FDA handed down Class I ratings to recent recalls from Medtronic and Baxter International, identifying that the safety issues carry a high risk of serious injury or death.
Medtronic received the classification for the latest in a long string of flaws discovered within the HeartWare Ventricular Assist Device (HVAD) system, which was finally discontinued last year after racking up more than a decade’s worth of patient complaints and subsequent recalls—but remains implanted in around 4,000 people.
Baxter, meanwhile, saw the Class I designation as an upgrade to an urgent medical device correction that it issued earlier this month for the Volara system that connects to a ventilator to help expand the lungs and clear out mucus.
Read the full article at Fierce Biotech.