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ev3 Inc. Recall 89229

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.

ev3 Inc. Recall 89229 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0450-2022
Event ID89229
Event DescriptionMedtronic 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.
Product TypeDevices
DistributionWorldwide 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.
Quantity71,260 units
Recall ReasonReports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Device Classification20220126
Device Code InfoH1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.
Center Classification Date20220119
Recall Initiation Date20211206
Recalling Firmev3 Inc.
Initial Notification Letter
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