ev3 Inc.: Medical Device Recalls in 2022

According to to data from the FDA, there were 4 medical device recalls made by ev3 Inc. in 2022. See the details of the recalls below.

You can see similar recalls for other firms.

• Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
• 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.
• 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.
• Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.