Recall Z-0695-2022 ยท MCW Catheter, Peripheral, Atherectomy
ev3 Inc.
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
| Date | Mar 7, 2022 (initiated Feb 4, 2022) |
| Status | Terminated |
| 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. |
| Root cause | Labeling design |
| Action | The recalling firm began issuing the URGENT MEDICAL DEVICE NOTICE dated February 2022 on 2/4/2022 via 2-day UPS delivery. The letter explained the issue and instructed the consignee to adhere to the existing IFU instructions and warnings and precautions listed in the letter to reduce the risk of guidewire prolapse. The Customer Instructions included the notice was to be shared with all who needed to be aware within the consignee's organization or to any other organization where the product has been transferred; to review the IFU included with the product prior to use, noting the warnings an |
| Quantity | 245 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212027 | TurboHawk Plus Directional Atherectomy System Medtronic, Inc., Aug 24, 2021 |