The Recall Desk

FDA (Devices) recall action 71756

Medtronic Navigation, Inc. recalled 2 products on 2015-08-12

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
2015-08-12
Critical
0
Units
2,830

Why these products were recalled

The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere assembly to move on the needle shaft. This may result in inaccurate navigation and improper placement of the needles biopsy window in the brain.

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.

1–2 of 2

  • SevereFDA (Devices)··2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because adhesive failure may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee Per Use (FPU) Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2015-08-12

    Medtronic Passive Biopsy Needle Kit Recalled for Adhesive Defect

    Medtronic is recalling 1,415 Passive Biopsy Needle Kits because compromised adhesive may cause the sphere assembly to move, leading to inaccurate navigation during brain biopsies.

    Product
    Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit. The image guided Passive Biopsy Needle is an accessory instrument with the StealthStation System. The Biopsy Needle is intended to be used for stereotaxy biopsy of brain tissue.
    Category
    Distribution
    0 states