Medtronic recalls TurboHawk Plus Directional Athrectomy System

Editor's Note

On February 7, Medtronic announced that it had issued a voluntary recall of its 6Fr TurboHawk Plus Directional Atherectomy System because of the risk of tip damage caused by guidewire prolapse.

To date, there have been no reports of tip damage and no reports of injuries or deaths related to this device.

There is no product retrieval or disposal requested at this time, and there are no actions required for patients treated with the 6Fr TurboHawk Plus or any of its directional atherectomy devices, Medtronic says.

Medtronic recently issued instructions for use (IFU) warnings and precautions related to instances of guidewire prolapse causing tip damage for the HawkOne Directional Atherectomy System. Based on design similarities, the same warnings and precautions apply to TurboHawk Plus.

The Food and Drug Administration identified the HawkOne recall as Class I.