An atherectomy is a procedure that removes blockages in peripheral arteries and improves bloodflow. Medical professionals have been using Medtronic HawkOne Directional Atherectomy Systems since 2016 for this procedure. The HawkOne uses a catheter that has been known to break or separate, especially at the tip of the catheter.
Despite its being approved by the U.S. Food and Drug Administration, the HawkOne catheter’s known issues can result in serious damage to blood vessels and even corrective surgeries. Medtronic issued a recall of 95,110 HawkOne systems distributed from January 22,2018, to October 3, 2021. The FDA has classified it as a Class 1 recall, which is the most serious type. The HawkOne received a 510(k) FDA approval, which allowed Medtronic to fast-track product development without clinical trials. The HawkOne also is credited with giving Medtronic control of 90% of the global market share for directional atherectomy devices.
Medtronic HawkOne Injuries and Side Effects
If the tip of the catheter breaks off, it can cause any of these serious injuries:
- Arterial dissection (a tear in the wall of your artery)
- Arterial rupture (when an artery breaks, causing internal bleeding)
- Ischemia (decreased blood flow caused by the artery being blocked)
- Blood vessel complications
If you required additional surgery after a procedure using the HawkOne Directional Atherectomy System, had further problems and complications after the procedure, or if your loved one died after their atherectomy, you may be eligible for compensation. If you believe that you have experienced these problems, give us a call. There is no obligation to join the Medtronic heart catheter recall claim, and your consultation is free.
Medtronic HawkOne Catheter RecallUse this form to let us know if you believe you have been affected by the Medtronic HawkOne Catheter recall.
The HawkOne™ Directional Atherectomy System is a registered trademark of Medtronic, Inc. and is used here only for the purpose of identifying the product in question. Woods & Woods, LLC is not affiliated with, sponsored by or associated with the U.S. Food & Drug Administration or Medtronic.