Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.

Abstract

Cardiovascular devices account for one third of all Class I recalls, the U.S. Food and Drug Administration's (FDA) most severe designation, indicating a reasonable probability of "serious adverse health consequences or death." Understanding recalls and their causes is important for patient safety. To characterize Class I recalls of cardiovascular devices and the clinical evidence supporting authorization. In this cross-sectional study, cardiovascular device recalls from 1 January 2013 through 31