Medtronic Navigation, Inc.: Medical Device Recall in 2015 - (Recall #: Z-2324-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: July 17, 2015

Date Posted: August 12, 2015

Recall Number: Z-2324-2015

Event ID: 71756

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1415 total

Code Information:

LOT No: 066503515, 066504315, 066506515

Distribution Pattern:

Worldwide Distribution - US (nationwide) and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated