Z-0695-2022 Class I Terminated
FDA device recall Z-0695-2022 was initiated by ev3 Inc. on February 4, 2022 and is designated Class I. 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. The recall status is terminated (terminated October 2, 2024). Affected quantity: 245 devices.
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
- 245 devices
Product Description
Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. 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 00763000402419