The FDA has said this is a Class I recall, which means using the devices “may cause serious injuries or death.” A total of 18 injuries have been reported so far. 

A group of renowned TAVR specialists examined data from 783 pairs of intermediate-risk patients, sharing their findings in the Journal of the American College of Cardiology.

After warning healthcare providers about a heightened risk of mortality back in 2019, the FDA has now updated its stance on the use of these devices. 

The North Carolina physician allegedly performed unnecessary atherectomy procedures to treat minor blockages in the leg arteries of multiple patients.

Researchers in Japan tracked BNP levels and bleeding events among more than 7,000 PCI patients. The group noted that managing heart failure in the first 30 days after PCI can help boost outcomes. 

The new-look DCB was designed to provide care with a significantly lower drug load than similar devices. 

The new device was designed to remove thrombi and emboli from peripheral arteries ranging from 2 to 4 mm.