Medtronic Issues Voluntary Recall For TurboHawk Plus Directional Atherectomy System

Medtronic Plc MDT has 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.

• Recently, Medtronic issued a recall for the HawkOne Atherectomy system due to tip damage risk, used during procedures intended to remove a blockage from peripheral arteries and improve blood flow. 
• In an emailed statement, the Company told Benzinga that due to design similarities, Medtronic had sent a notice emphasizing the same warnings and precautions apply for the TurboHawk Plus Directional Atherectomy System. 
• This is not a new issue, and there is no product retrieval or disposal requested based on this notice. 
• This notice impacts approximately 800 devices. There have been zero reports of tip damage and zero reports of injury or death on the TurboHawk Plus device. 
• This communication reiterates the warnings and precautions in the TurboHawk Plus Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire prolapse.  
• Price Action: MDT shares are down 0.21% at $102.51 during the market session on the last check Monday.