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Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small 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.

Lot codes and dates: H1-S - Irvine GTIN 00643169792319
Galway GTIN 00643169968356. H1-S-INT
Irvine GTIN 00643169728790
Galway GTIN 00643169968530
Amount recalled: 28,094 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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