On December 6, 2021, Medtronic recalled the HawkOne Directional Atherectomy System (OneHawk system), and the U.S. Food and Drug Administration (FDA) classified the recall as Class 1 due to its potential to cause serious injuries and death.
The Medtronic HawkOne system is an artery-cleaning device that includes a catheter and a power cutter. The device is designed to remove plaque build-ups inside peripheral arteries by spinning at speeds up to 12,000 RPM. The issue with the device is that the guidewire in the catheter can become bent and stick outward during use which can cause the catheter’s tip to separate or break off. This can cause serious complications such as tearing inside the artery’s walls (arterial dissection), rupture or breakage of an artery (arterial rupture), a decrease in blood flow to parts of the body due to the blocked artery ischemia), and blood vessel complications that could require surgery to find, capture, and remove the catheter tip in addition to procedures to repair the damage.
So far, the U.S. FDA has received 163 complaints that included 55 injuries. The recall covers more than 95,000 devices in the U.S. that were distributed from January 22, 2018, through October 4, 2021.
How GoldenbergLaw Can Help You
If you or a loved one suffered a complication from a Medtronic HawkOne system, contact the Minneapolis Medical Device Attorneys at GoldenbergLaw. Our team has more than 35 years of experience providing the Gold standard of advocacy to our clients. We have the expertise, experience, and compassion to help you get the justice you deserve. Contact us today for a free consultation.