On Feb. 7, Medtronic issued a notice emphasizing that the same warnings and precautions issued for the HawkOne directional atherectomy system also apply for the company’s TurboHawk Plus 6Fr system due to design similarities. The company stresses that this is not a new issue.
“There is no product retrieval or disposal requested at this time,” Medtronic communicates in a news alert, which details that approximately 800 devices are impacted by this recall. “Additionally, there are no actions required for patients treated with the TurboHawk Plus 6Fr or any Medtronic directional atherectomy devices,” the alert continues.
Medtronic advises that there have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device.