Z-0694-2022 Class I Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 16, 2022
- Initiation Date
- February 4, 2022
- Termination Date
- October 2, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 441 devices
Product Description
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
Reason for Recall
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.
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.
Code Information
GTIN 00763000402396