ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog nu
Recalled Product
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.
Hazard / Issue
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Issued by
FDA
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