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.

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

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 prolapse. The consignee is informed reports have been received of tip damage during use of 6Fr HawkOne devices which has resulted in some instances of tip detachment and embolization. The consignees are informed that no updates will be applied to the current HawkOne IFU at this time and patients should continue to be monitored per the practice's normal follow-up procedures. There are no actions required for patients where HawkOne was previously used during a procedure and there are no product retrievals or disposals requested by Medtronic. Customer Instructions provided in the letter include the following actions be immediately taken: (1) Share with all those who need to be aware within their organization or to any organization where the products have been transferred; (2) Prior to use, the IFU is to be reviewed noting the warnings and precautions listed in this letter; and (3) The enclosed Customer Confirmation Form is to be completed and emailed to the recalling firm. The confirmation form is for the customer to sign and date to acknowledge receipt of the enclosed letter and email to: [email protected]. If you have any questions regarding this issue or communication, please contact your Medtronic Field Representative or email: [email protected].