Recalled Cardiovascular Devices Rarely Undergo Sufficient Testing

A new analysis of recalled cardiovascular devices published in the Annals of Internal Medicine found that most of them hadn’t gone through clinical testing before they were authorized. And when they were, the evidence was usually based on 1 non–randomized clinical trial. The researchers used data from the US Food and Drug Administration (FDA) Class I recalls from 2013 to 2022. There were 137 recalls involving 157 unique cardiovascular devices.