Medtronic recalls a second directional atherectomy device due to risk of tip damage
Medtronic has announced a voluntary recall of its 6 French TurboHawk Plus Directional Atherectomy System, an interventional solution designed to remove blockages in a patient’s legs. The recall is related to potential issues with the catheter’s guidewire moving or prolapsing during use, which can lead to adverse events.
Medtronic emphasized that there have been no reports of incidents with this device. The company recently recalled its HawkOne Directional Atherectomy System due to the risk of prolapse, however, and has now decided to recall the TurboHawk system due to similarities between the two devises.
Approximately 800 devices are included in this latest recall. Medtronic has told both patients and clinicians that no actions need to be taken—the company is not retrieving impacted devices. Instead, Medtronic aims to “reiterate the existing warnings and precautions” included in the TurboHawk system’s instructions that detail the risk of tip damage caused by guidewire prolapse.
“Physicians should continue to monitor patients in accordance with their medical facility’s standard care protocols,” the company said in a statement.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.