Medtronic Passive Biopsy Needle Kit — Class II medical device recall Z-2325-2015
Terminated recall by Medtronic Navigation, Inc., reported 2015-08-12, distributed nationwide. The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing the sphere as
| Recall number | Z-2325-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2015-07-17 |
| Classified | 2015-08-03 |
| Reported by FDA | 2015-08-12 |
| Terminated | 2016-04-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 1,415 total |
| Lot numbers | 0007525461, 0007599312 |
| Model numbers | 9731754 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2325-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.