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 | Ongoing |
| 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 |
| Similar To |