Recall Z-0450-2022— ev3 Inc.

Name: FDA recall Z-0450-2022
Creator: U.S. Food and Drug Administration
Published: 2021-12-06

Class I · Terminated

Class I FDA medical device recall by ev3 Inc., initiated 2021-12-06, terminated 2024-10-02. It names one FDA 510(k) clearance: K161361. Product: 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.. Reason: Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization..

Recalling firm: ev3 Inc.
Classification: Class I
Status: Terminated
Initiated: 2021-12-06
Terminated: 2024-10-02
Firm location: Plymouth, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K161361 — HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc.·cleared 2016-10-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

Data sourced from openFDA. This site is unofficial and independent of the FDA.