Most cardiovascular devices with serious safety recalls aren’t tested in patients
Sept. 16, 2024
Health Tech Correspondent
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.
advertisement
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.
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — and get additional analysis of the technologies disrupting health care — by subscribing to STAT+.
Already have an account? Log in
Monthly
$39
Totals $468 per year
$39/month Get StartedTotals $468 per year
Starter
$20
for 3 months, then $399/year
$20 for 3 months Get StartedThen $399/year
Annual
$399
Save 15%
$399/year Get StartedSave 15%
11+ Users
Custom
Savings start at 25%!
Request A Quote Request A QuoteSavings start at 25%!
2-10 Users
$300
Annually per user
$300/year Get Started$300 Annually per user
View All Plans
To read the rest of this story subscribe to STAT+.
Subscribe Log In FDA, Medical devices, STAT+ Submit a correction requestReprints
Newsletter
Tech is transforming health care and life sciences. Our original reporting is here to keep you ahead of the curve.
