Firm-Wide blog

FDA Issues Class I Recall for Medtronic HawkOne Directional Atherectomy System

By Burg Simpson
January 21, 2022
3 min read
Recall for Medtronic HawkOne Directional Atherectomy System

By Burg Simpson Ohio

FDA Issues Class I Recall for Medtronic HawkOne Directional Atherectomy System

On January 21, 2022, the U.S. Food and Drug Administration (FDA) issued a Class I recall notice for the Medtronic HawkOne Directional Atherectomy System. An FDA Class I recall is the most serious type of recall. Use of this device has an increased risk serious adverse events such as severe injury or death. A total of 95,110 devices distributed between January 22, 2018 to October 4, 2021 are subject to this recall.

The HawkOne Directional Atherectomy System is currently approved for removing plaque from patients with peripheral arterial disease (typically in the arms and legs).

On December 6, 2021, Medtronic began recalling this device system due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied improperly. This force can cause the catheter tip to break off or separate causing potential serious adverse events such as: a tear along the inside wall of an artery (arterial dissection), a rupture or breakage of an artery (arterial rupture), decrease in blood flow to a part of the body because of a blocked artery (ischemia), and/or other blood vessel complications.

If you are a loved one have suffered injuries you believe were caused by Medtronic HawkOne Directional Atherectomy System, contact one of the experienced product liability attorneys at Burg Simpson today. Our award-winning lawyers would be happy to discuss your potential claim. Call (800) 713-9340 or fill out our contact form for a FREE no-obligation consultation today.

About Burg Simpson Eldredge Hersh & Jardine

One of America’s foremost plaintiff trial firms, Burg Simpson Eldredge Hersh & Jardine, has a longstanding and nationwide reputation for fighting relentlessly and successfully for victims of negligence, malfeasance, malpractice, and abuse. Our award-winning attorneys have never hesitated to fight for our client’s rights and consistently face and defeat formidable adversaries that include big insurance companies, big banks, and big pharma. Burg Simpson has secured more than $2.7 billion in verdicts, settlements, and judgments in practice areas spanning catastrophic personal injury, mass tort and class actions regarding gas explosions, dangerous pharmaceutical drugs and devices, medical malpractice, complex commercial and business litigation, construction defects, and workers’ compensation. The firm’s success has also included more than 200 recoveries in excess of $1 million.

Burg Simpson Eldredge Hersh & Jardine now has more than 75 lawyers and over 90 legal professionals. The firm is based in Colorado and has offices in Arizona, Florida, Nevada, New Mexico, Ohio, California, and Wyoming.

Contact Burg Simpson Now

Free case evaluation form