FDA-Device2022-03-16Class I
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
ev3 Inc.
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.
Sold states
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.
Affected count
245 devices
Manufactured in
4600 Nathan Ln N, N/A, Plymouth, MN, United States
Products
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2022Don't want to check this manually?
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