FDA recall Z-0695-2022

Product

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

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.

Key facts

Status

Terminated

Initiation date

2022-02-04

Report date

2022-03-16

Termination date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plymouth, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0695-2022