FDA Device recall Z-2324-2015
Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit
- FDA Device
- Class II
- terminated
- Published 2015-08-12
On 2015-08-12 the FDA classified a Class II recall of Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Needle Kit by Medtronic Navigation, citing 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 nav….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2324-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-17 |
| Published | 2015-08-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Navigation |
| Distribution | US |
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.
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.
Identifiers
| code_info | LOT No: 066503515, 066504315, 066506515 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2324-2015%22
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