ev3 Inc.: Medical Device Recall in 2022 - (Recall #: Z-0695-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

Product Classification:

Class I

Date Initiated: February 4, 2022

Date Posted: March 16, 2022

Recall Number: Z-0695-2022

Event ID: 89470

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.

Status: Terminated

Product Quantity: 245 devices

Code Information:

GTIN 00763000402419

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.

Voluntary or Mandated:

Voluntary: Firm initiated