On January 21, 2022, the FDA announced a Class I recall, the most serious type of recall, of Medtronic Inc.’s (“Medtronic”) HawkOne Directional Atherectomy System due to the risk of the guidewire within the catheter moving downward or prolapsing when force is applied during use. There have been 163 complaints about this issue with the HawkOne Directional Atherectomy System, with 55 injuries and no deaths reported about this device issue.
The HawkOne Directional Atherectomy System consists of a catheter and a cutter driver. This device is used during procedures intended to remove blockage from peripheral arteries and improve blood flow.
If the guidewire within the catheter moves downward or prolapses when force is applied during use, the catheter tip may break off or separate and this could lead to serious adverse events including 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 blood vessel complications that could require surgical repair and additional procedures to capture and remove the detached and/or migrated (embolized) tip.
The recalled devices were distributed from January 22, 2018 to October 4, 2021. Medtronic issued the recall on December 6, 2021 when it sent an “Urgent Medical Device Notice” letter to customers requesting they share with all those who need to be aware within the organization or to any organization where the products have been transferred, and before using the HawkOne Directional Atherectomy System, review the “Instructions For Use” included with the product, noting the warnings and precautions listed in the “Urgent Medical Device Notice” letter.
On its website, Medtronic describes the HawkOne Directional Atherectomy System as follows: “The HawkOne peripheral directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX™ embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is NOT intended for use in the coronary, carotid, iliac or renal vasculature.”
“Treat above and below the knee with the HawkOne™ directional atherectomy system to restore blood flow by removing plaque in patients with peripheral arterial disease (PAD). The HawkOne device treats all plaque morphologies, including severe calcium. Enhanced crossing and simpler cleaning make your procedure more efficient. If your treatment goal is to make a small channel or to maximize luminal gain, choose the Medtronic directional atherectomy system to preserve a patient’s native vessel and keep future treatment options open.”
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