FDA Issues Class I 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.
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