Recall Z-0451-2022 ยท MCW Catheter, Peripheral, Atherectomy
ev3 Inc.
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
| Date | Jan 19, 2022 (initiated Dec 6, 2021) |
| Status | Terminated |
| Reason | Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization. |
| Root cause | Labeling design |
| Action | The firm, Medtronic, issued an "URGENT MEDICAL DEVICE NOTICE" dated December 2021 on 12/6/2021 via 2-day UPS delivery to consignees who have the affected product. Outside of the United States, beginning 12/6/2021, the letter was being delivered via regionally-approved methods to the consignees. The letter describe the product, problem and actions to be taken. The consignees were instructed to do the following The letters The letter reiterates the existing warnings and precautions in the HawkOne Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire pr |
| Quantity | 28,094 units |
| 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, Israe |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161361 | HawkOne Directional Atherectomy System Medtronic Vascular, Inc., Oct 14, 2016 |