Wallace & Graham Blog Faulty Valve Leads FDA to Issue a Recall of Heart Device Made by Johnson & Johnson

On January 2, 2018, the U.S. Food and Drug Administration (FDA) issued a Class I recall impacting 112 units of Agilis Steerable Introducer Sheath devices manufactured and sold by Johnson & Johnson between January 1st and May 5th, 2017. The Class I recall of the heart device is the strictest type of recall issued by the agency, and is only...Read more →