ev3 Inc. Recall 89470
Description: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
ev3 Inc. Recall 89470 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0695-2022 |
Event ID | 89470 |
Event Description | Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. |
Product Type | Devices |
Distribution | 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. |
Quantity | 245 devices |
Recall 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. |
Device Classification | 20220316 |
Device Code Info | GTIN 00763000402419 |
Center Classification Date | 20220307 |
Recall Initiation Date | 20220204 |
Recalling Firm | ev3 Inc. |
Initial Notification | Letter |
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