Class 1 Device Recall HawkOne

• Date Initiated by Firm: December 06, 2021
• Date Posted: January 19, 2022
• Recall Status: Terminated on October 02, 2024
• Recall Number: Z-0451-2022
• Recall Event ID: 89229
• 510(K)Number: K161361
• Product Classification: Catheter, peripheral, atherectomy - Product Code MCW
• Product: 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 severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.
• Code Information: H1-S - Irvine GTIN 00643169792319, Galway GTIN 00643169968356. H1-S-INT, Irvine GTIN 00643169728790, Galway GTIN 00643169968530.
• Recalling Firm/ Manufacturer: ev3 Inc.; 4600 Nathan Ln N; Plymouth MN 55442-2890
• For Additional Information Contact: Medtronic Customer Service; 800-854-3570
• Manufacturer 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.
• FDA Determined 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 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: rs.cfqfca@medtronic.com. If you have any questions regarding this issue or communication, please contact your Medtronic Field Representative or email: rs.recalls@medtronic.com.
• Quantity in Commerce: 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, 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MCW