FDA Device recall Z-0450-2022
Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014"…
- FDA Device
- Class I
- terminated
- Published 2022-01-26
On 2022-01-26 the FDA classified a Class I recall of Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014"… by Ev3, citing reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0450-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2021-12-06 |
| Published | 2022-01-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ev3 |
| Distribution | US |
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
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Identifiers
| code_info | H1-M - Irvine GTIN 00643169792302, Galway GTIN 00643169968332. H1-M-INT - Irvine GTIN 00643169728776, Galway, GTIN 00643169968523. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0450-2022%22
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