ev3 Inc. Recall: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M
ev3 Inc. Recall: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: ev3 Inc.; Product: Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath,
| Recalling firm | ev3 Inc. |
|---|---|
| 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 for recall | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
| Classification | Class I (most serious — reasonable probability of serious health consequences or death) |
| Status | Terminated |
| Distribution | 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, |
| Recall initiated | 20211206 |
| Recall number | Z-0450-2022 |
| Category | device |
| State | MN |
| Country | United States |
$29/mo
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