FDA: Class I recall of Medtronic TurboHawk Plus Directional Atherectomy System

Editor's Note

The Food and Drug Administration, on March 9, identified the recall by Medtronic of its TurboHawk Plus Directional Aherectomy System as Class I, the most serious.

The recall was initiated because of the risk of the guidewire in the catheter moving downward or prolapsing when force is applied during use. If this happens, the catheter tip may break off or separate while inside the artery, which could lead to arterial dissection, arterial rupture, ischemia, and/or complications that could require repair and/or procedures to remove the detached tip.

As of February 7, 2022, no injuries or deaths associated with this problem have been reported.