FDA-Device2015-08-12Class II
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.
Medtronic Navigation, Inc.
Hazard
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.
Sold states
Worldwide Distribution - US (nationwide) and Canada.
Affected count
1415 total
Manufactured in
826 Coal Creek Cir, N/A, Louisville, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2325-2015Don't want to check this manually?
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