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Recall Observatory FDA recall evidence

Device 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.

Z-2324-2015

July 17, 2015

Class II

Product summary

Firm
Medtronic Navigation, Inc.
Event
Event 71756
Status
Terminated
Classification
Class II
Quantity
1415 total
Official record key
device-enforcement:Z-2324-2015

Official wording

Reason: 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.

Code information: LOT No: 066503515, 066504315, 066506515

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.