FDA Provides Update on Medtronic’s Recall of HawkOne Directional Atherectomy System

The FDA has issued on update on Medtronic’s Dec. 6, 2021, recall of its HawkOne directional atherectomy system, deeming it a Class 1 recall because of the risk of serious injury or death.

The device, which includes a catheter and a cutter driver, is used to remove blockages from peripheral arteries.

The reason for the recall is the risk of the guidewire within the catheter moving downward when force is applied during use, which can cause the catheter tip to break off. This could result in serious adverse events, such as a tear along the inside wall of an artery, or other complications that could require surgical repair and additional procedures to capture and remove the detached tip.

There have been 163 complaints about the recalled device, including 55 reported injuries, but no deaths so far, the agency said. The 95,110 affected products were distributed from Jan. 22, 2018, to Oct. 4, 2021.