The Recall Desk

FDA (Devices) recall action 89229

ev3 Inc. recalled 2 products on 2022-01-26

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-01-26
Critical
1
Units
99,354

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • CriticalFDA (Devices)··2022-01-26

    Medtronic HawkOne Atherectomy System Recalled for Tip Detachment and Embolization Risk

    Medtronic is recalling the HawkOne Directional Atherectomy System globally due to reports of tip damage that can detach and cause embolization. The device is used to remove arterial plaque in peripheral blood vessels.

    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
    Category
    Distribution
    1 state
  • SevereFDA (Devices)··2022-01-26

    Medtronic HawkOne Directional Atherectomy Device Recalled for Tip Damage

    Medtronic is recalling 28,094 units of its HawkOne directional atherectomy system due to reports of catheter tip damage and detachment that can cause blood clots in blood vessels.

    Product
    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.
    Category
    Distribution
    1 state