The Recall Desk

FDA (Devices) recall action 89470

ev3 Inc. recalled 2 products on 2022-03-16

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
2022-03-16
Critical
0
Units
686

Why these products were recalled

The device has similarities in design to another device that the firm recently issued a field correction on due to 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

  • SevereFDA (Devices)··2022-03-16

    Medtronic TurboHawk Plus atherectomy system recalled for potential tip detachment

    The Medtronic TurboHawk Plus Directional Atherectomy System (catalog THP-S) is being recalled due to design similarities to another device that experienced tip detachment and embolization. The recall affects 245 devices distributed nationwide.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
    Category
    Distribution
    18 states
  • SevereFDA (Devices)··2022-03-16

    Medtronic TurboHawk Plus Directional Atherectomy System Recalled Due to Design Defect

    ev3 Inc. is recalling the Medtronic TurboHawk Plus Directional Atherectomy System due to design similarities to a device with reported tip detachment and embolization incidents. The FDA has classified this as a Class I recall.

    Product
    Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.
    Category
    Distribution
    18 states