Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk
Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is rated Critical because it is an FDA Class I recall. The hazard involves actual instances of device malfunction (tip detachment) that resulted in embolization—a serious vascular emergency with potential for stroke or tissue necrosis.
Plain-English summary
Medtronic's HawkOne Directional Atherectomy System (catalog numbers H1-M and H1-M-INT) is being recalled worldwide. The system is designed for atherectomy—removal of plaque buildup—in peripheral blood vessels outside the heart. It is intended for use with the SpiderFX embolic protection device when treating severely calcified lesions.
Reports have been received of tip damage occurring during device use. In some instances, the damaged tip has detached and caused embolization—the lodging of foreign material in blood vessels. This can potentially lead to stroke, tissue damage, or other serious vascular complications.
The HawkOne system has been distributed in the United States (including Puerto Rico) and 40 additional countries worldwide. Approximately 71,260 units were affected by this recall.
Healthcare providers should immediately cease use of recalled devices and verify that their HawkOne units are not part of this recall. Contact Medtronic or the FDA for further information. Patients who have undergone HawkOne procedures should contact their healthcare provider if they experience symptoms suggestive of vascular complications, such as sudden weakness, chest pain, or breathing difficulties.
The recalled product
- 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
- Manufacturer
- ev3 Inc.
- Hazard
- tip-damage
- tip-detachment
- embolization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- H1-M - Irvine GTIN 00643169792302
- Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776
- Galway
- GTIN 00643169968523.
Distribution
Distributed nationwide across the United States.
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