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ev3 Inc. recalls Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral va
Recalled March 16, 2022 · FDA recall Z-0694-2022 · ev3
Hazard
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. · FDA Class I
Units
441 devices
Sold at
US Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
Description
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.
Product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Manufacturer(s)
ev3 Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →