Approval-adjusted recall rates of high-risk medical devices from 2002-2016 across food and drug administration device categories.

Abstract

Between 2002 and 2016, 806 million medical devices were recalled. When approving a device, the FDA employs advisory boards organized by medical specialty (e.g. cardiovascular) to make approval recommendations. Previous work has demonstrated high numbers of recalled orthopedic and cardiovascular devices; however, no prior studies have controlled for the number of approvals by advisory board. The purpose of this study is to identify device fields at higher risk for safety problems. This study comp