The Recall Desk

FDA (Devices) recall action 72409

Boston Scientific Corporation recalled 2 products on 2015-11-18

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
2015-11-18
Critical
0
Units
—

Why these products were recalled

Boston Scientific is recalling its recently released RotaWire Elite Guidewire and wireClip Torquer Guidewire Manipulation device that is used in conjunction with the Rotablator Rotational Atherectomy System because of complaints of wire fracture.

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

States named across these recalls

1–2 of 2

  • SevereFDA (Devices)··2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices due to complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Extra Support. REF H802233301 (5-pack outer package), REF H802233300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed…
    Category
    Distribution
    17 states
  • SevereFDA (Devices)··2015-11-18

    Boston Scientific Recalls RotaWire Elite Guidewires Due to Wire Fracture Complaints

    Boston Scientific is recalling RotaWire Elite Guidewires and wireClip Torquer devices because of complaints of wire fracture. The devices are used with the Rotablator Rotational Atherectomy System.

    Product
    RotaWire Elite and wireClip Torquer, Guidewire and Guidewire Manipulation Device, Floppy. REF H802223301 (5-pack outer package), REF H802223300 (single unit). The Rotablator rotational atherectomy system consists of a diamond tipped burr capable of high speed rotation…
    Category
    Distribution
    17 states