ev3 Inc.: 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.

Recall number

Z-0450-2022

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.

Status

Terminated

Initiated

2021-12-06

Posted

2022-01-19

Terminated

2024-10-02

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 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

71,260 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.

Lot, serial or model codes

H1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.

510(k) numbers

["K161361"]

PMA numbers

not on file

Product code

MCW

Firm FEI

2183870

Firm city

Plymouth

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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