FDA: Class I recall of Medtronic’s HawkOne Directional Atherectomy System

Editor's Note

The Food and Drug Administration (FDA) on January 21 identified the recall by Medtronic Inc of its HawkOne Directional Atherectomy System as Class I, the most serious.

The recall was initiated because of the risk of the guidewire within the catheter moving down ward or prolapsing when force is applied during use. If this happens, the catheter tip could break off or separate.

The System is used to remove blockage from peripheral arteries and improve blood flow.

There have been 163 complaints, 55 injuries, and no deaths reported about this device issue.

Distribution dates were January 22, 2018 to October 4, 2021.