# FDA recall Z-0695-2022

> **ev3 Inc.** · Class I · device recall initiated 2022-02-04.

## 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

- **Recall number:** Z-0695-2022
- **Recalling firm:** ev3 Inc.
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0695-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0695-2022. Source: US FDA. Licensed CC0.

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