Medtronic (NYSE:MDT) today announced that it issued a voluntary recall for its TurboHawk 6 French (6Fr) Plus directional atherectomy system.
The recall for the TurboHawk Plus system relates to the risk associated with tip damage caused by guidewire prolapse. A recall for the HawkOne directional atherectomy system — associated with a similar issue — was deemed Class I by the FDA last month.
Fridley, Minnesota-based Medtronic said in a news alert that the recall impacts approximately 800 TurboHawk Plus devices. However, there have been zero reports of tip damage and zero reports of injury or death on the device. The company made the recall based on design similarities between the TurboHawk Plus and HawkOne systems. Hence, the same warnings and precautions apply.
There is no product retrieval or disposal requested at present, and there are no actions required for patients treated with the TurboHawk Plus 6Fr or any of Medtronic’s directional atherectomy devices.