FDA Device recall Z-0217-2024
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40
- FDA Device
- Class II
- completed
- Published 2023-11-08
On 2023-11-08 the FDA classified a Class II recall of LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40 by Medtronic Neuromodulation, citing there are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0217-2024 |
| Classification | Class II |
| Status | completed |
| Initiated | 2022-05-27 |
| Published | 2023-11-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | FL, MO, TX, WA |
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Reason
There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use By Date (UBD) printed on the outer packaged kit label versus the UBD printed on the individual product label.
Identifiers
| code_info | UDI/DI 00763000274320, Serial Number VA2JV2V |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0217-2024%22
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