Use cautionMedical device recall · FDA · Published December 6, 2021
Medtronic HawkOne Directional Atherectomy System Recall: Tip Damage Risk
Medtronic recalls HawkOne Directional Atherectomy System (H1-M and H1-M-INT) due to tip damage causing detachment and embolization. Affected units sold in specific regions with catalog numbers.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
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📍Recalling firmev3 Inc.4600 Nathan Ln N · Plymouth, MN 55442-2890
✎ GovInfoNow plain-language explainer
Medtronic is recalling its HawkOne Directional Atherectomy System (catalog numbers H1-M and H1-M-INT) because reports show tip damage during use can lead to detachment and embolization. This poses a risk of blockages in blood vessels, which could cause serious complications for patients undergoing vascular procedures. Read more at govinfonow.com/recall/61464-medtronic-hawkone-directional-atherectomy-system-recall-tip-damage-risk.
“Medtronic HawkOne Directional Atherectomy System Recall: Tip Damage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61464-medtronic-hawkone-directional-atherectomy-system-recall-tip-damage-risk. Based on FDA recall #Z-0450-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0450-2022%22&limit=1).
The FDA announced on Dec. 6, 2021, that ev3 Inc. is recalling Medtronic HawkOne Directional Atherectomy Systems due to tip damage risks. The agency classified the recall as Class I.
The FDA reported that tip damage during use resulted in some instances of tip detachment and embolization. The device is intended for use in atherectomy of the peripheral vasculature.
Context
GovInfoNow's records show ev3 Inc has had 3 other recalls since Aug. 26, 2020. Other recent recalls include the Medtronic NanoCross Elite PTA Catheter Recall (Dec. 10, 2024), the ev3 TurboHawk Plus Atherectomy System Recall (Feb. 4, 2022), and the ev3 Pacific Xtreme Balloon Catheter Recall (Aug. 26, 2020). Other recent recalls of similar products include the Medtronic Harmony Catheter System Recall (May 22, 2026), the Boston Scientific Imager II Angiographic Catheters Recall (Aug. 24, 2026), and the Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (July 9, 2026).
How to tell if you have this one
Check for catalog numbers H1-M or H1-M-INT on the device packaging. The system is sold in the U.S. and Europe with specific GTINs listed in the recall notice.
Brand
Medtronic
Product
ev3 Inc. recalls Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm)
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class I
Status
Terminated
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.
Recall number
Product, codes & lots
Quantity
Z-0450-2022
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.; H1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523.
71,260 units
Z-0451-2022
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.; H1-S - Irvine GTIN 00643169792319, Galway GTIN 00643169968356. H1-S-INT, Irvine GTIN 00643169728790, Galway GTIN 00643169968530.
28,094 units
Based on the official FDA remedy
What to do — step by step
Check Device Packaging
Look for catalog numbers H1-M or H1-M-INT on the device packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.8 years after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall does not require immediate discontinuation; however, users should check the device packaging for catalog numbers to confirm if it is affected.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0450-2022 (December 6, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0450-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.