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ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommend
Recalled January 26, 2022 · FDA recall Z-0451-2022 · ev3
Hazard
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. · FDA Class I
Units
28,094 units
Sold at
Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Korea, Republic Of Macao, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, and United Kingdom.
Description
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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.
Manufacturer(s)
ev3 Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →