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.
Reported: August 12, 2015 Initiated: July 17, 2015 #Z-2325-2015
Product Description
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.
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.
Details
- Recalling Firm
- Medtronic Navigation, Inc.
- Units Affected
- 1415 total
- Distribution
- Worldwide Distribution - US (nationwide) and Canada.
- Location
- Louisville, CO
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Medtronic Navigation, Inc.. Units affected: 1415 total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2015. Severity: Moderate. Recall number: Z-2325-2015.
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