Medtronic Recalls TurboHawk Atherectomy System

Medtronic has recalled its 6 French (6Fr) TurboHawk Plus directional atherectomy system because of the risks associated with potential tip damage.

The reason for the recall is the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use, which can cause the catheter tip to break off or separate.

The recall is related to the company’s Dec. 6, 2021, recall of its HawkOne directional atherectomy system, which the FDA has deemed a Class 1 recall because of the risk of serious injury or death.