1. FDA Issues Early Alert: Cook Medical Sizing Catheters Risk Marker Band Breakage During Angiograms
The U.S. Food and Drug Administration (FDA) has issued an urgent early alert for a critical device failure risk. Cook Medical's sizing catheters, used in standard angiographic procedures, may have marker bands that are at an increased risk of cracking or breaking during use. This is not a recall but a critical safety n...