STAT+: Most cardiovascular devices with serious safety recalls aren't tested in patients

When someone’s heart doesn’t beat quite right, an implantable defibrillator can save their life. The devices can jump-start a misbehaving heart, resetting its normal rhythm — unless they malfunction first. In 2022, Medtronic recalled more than 85,000 of the devices after dozens of complaints that a technical glitch could stop them from delivering the right, high-voltage shock. 

That recall is just one of 157 captured in a new analysis of cardiovascular devices in Annals of Internal Medicine by a team of researchers from Harvard, Yale, and the University of California San Francisco. They dug into a decade of documents from the Food and Drug Administration to understand how devices recalled for their risk of serious injury or death were clinically tested before being used on patients. 

In most cases, they simply weren’t. Among the 157 cardiovascular devices impacted by those serious recalls, only 30 had clear documentation of premarket clinical testing. 

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