Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and ...



Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small 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.
Components:
Recall Date:    Dec 6, 2021
Mfg:
ev3 Inc.
Mfg Country:
United States
Recall ID:    89229
Product ID:    190894
Enforcement Date:    Jan 26, 2022
Last Published:    Jan 21, 2022

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Emert Number:    Z-0451-2022
Emert Status:    Updated