Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic HawkOne Directional Atherectomy System Recalled by ev3 Inc. Due to Reports have been received of tip damage during...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ev3 Inc. directly.
Affected Products
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire. The HawkOne 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.
Quantity: 71,260 units
Why Was This Recalled?
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ev3 Inc.
ev3 Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report