Medtronic has recalled 95,110 HawkOne Directional Atherectomy Systems because of the risk of the guidewire within the catheter moving downward or prolapsing during use, which may damage the tip of the catheter … The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type, because of the potential for serious injury or death … The HawkOne Directional Atherectomy system … read more