Device product
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Z-0695-2022
Product summary
- Firm
- ev3 Inc.
- Event
- Event 89470
- Status
- Terminated
- Classification
- Class I
- Quantity
- 245 devices
- Official record key
device-enforcement:Z-0695-2022
Official wording
Reason: 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.
Code information: GTIN 00763000402419
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.