The US Food & Drug Administration (FDA) has issued a Class 2 device recall on the Medtronic HawkOne device, reminding consignees Medtronic has issued an “Urgent medical device notice” dated December 2021 regarding the HawkOne Directional Atherectomy System (catalogue 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.
Medtronic issued letters to consignees reiterating 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 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 organisation or to any organisation 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 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: rs.cfqfca@medtronic.com.
For more information, email: rs.recalls@medtronic.com.
FDA device recall notice (Open access)