In accordance with our commitment to patient safety, Medtronic recently initiated a voluntary recall to customers related to the risk associated with tip damage caused by guidewire prolapse in its 6 French (6Fr) TurboHawk™ Plus Directional Atherectomy System.

Approximately 800 Turbohawk Plus devices are impacted by this recall. There have been zero (0) reports of tip damage and zero (0) reports of injury or death on the TurboHawk Plus device. Medtronic recently issued 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 device. This is not a new issue.

This communication is to reiterate the existing warnings and precautions in the TurboHawk Plus Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire prolapse.

There is no product retrieval or disposal requested at this time. Additionally, there are no actions required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices. Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols.

For more information, please contact:
Krystin Hayward
Public Relations
+1-508-298-8246