The Recall Desk

FDA (Devices) recall action 75124

Medtronic Navigation, Inc. recalled 2 products on 2016-11-09

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
2016-11-09
Critical
0
Units
200

Why these products were recalled

Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.

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

  • HighFDA (Devices)··2016-11-09

    Medtronic Recalls Visualase Visualization Stylets Due to MRI Magnetic Attraction

    Medtronic Navigation is voluntarily recalling Visualase Visualization Stylets because they bend or pull toward magnetic fields during MRI procedures.

    Product
    Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Distribution
    4 states
  • HighFDA (Devices)··2016-11-09

    Medtronic Visualase Body Accessory Kit Recalled for MRI Safety Hazard

    Medtronic Navigation is recalling Visualase Body Accessory Kits because the visualization stylet bends in MRI magnetic fields.

    Product
    Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches. The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile. The…
    Category
    Distribution
    4 states