Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Medtronic TurboHawk Plus Directional Atherectomy System 6F Recalled by ev3 Inc. Due to The device has similarities in design to another...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ev3 Inc. directly.
Affected Products
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Quantity: 441 devices
Why Was This Recalled?
The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ev3 Inc.
ev3 Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report