Medtronic HawkOne Directional Atherectomy System — Class I medical device recall Z-0450-2022
Terminated recall by ev3 Inc., reported 2022-01-26, distributed nationwide. Reports have been received of tip damage during use of the devices which resulted in some instances of tip det
| Recall number | Z-0450-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ev3 Inc., Plymouth, MN, United States |
| Recall initiated | 2021-12-06 |
| Classified | 2022-01-19 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2024-10-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BR, CH, CL, CO, CR, CY, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HK, HR, IE, IL, IN, IT, JO, KR, NL, NO, NZ, OM, PE, PL, PT, SA, SE, SG, SI, SK, TH, TR, TW, ZA |
| Quantity | 71,260 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00643169728776, 00643169792302, 00643169968332, 00643169968523 |
| Model numbers | H1-M, H1-M-INT |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0450-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.