# FDA recall Z-0450-2022

> **ev3 Inc.** · Class I · device recall initiated 2021-12-06.

## Product

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire.   The HawkOne directional atherectomy system is intended for use in atherectomy of the peripheral vasculature. The HawkOne catheter is indicated for use in conjunction with the SpiderFX embolic protection device in the treatment of severely calcified lesions. The HawkOne catheter is not intended for use in the coronary, carotid, iliac, or renal vasculature.

## Reason for recall

Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

## Distribution

Worldwide Distribution:  US (nationwide), including PR; and  Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Jordan, Korea, Republic  Of Macao, Netherlands, New Zealand, Norway, Oman, Peru, Poland, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Turkmenistan, United Arab Emirates, and United Kingdom.

## Key facts

- **Recall number:** Z-0450-2022
- **Recalling firm:** ev3 Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-12-06
- **Report date:** 2022-01-26
- **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-0450-2022

## Citation

> AI Analytics. FDA recall Z-0450-2022. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0450-2022. Source: US FDA. Licensed CC0.

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