LEAD 3387S-40 STIMLOC DBS — Class II medical device recall Z-0217-2024
Completed recall by Medtronic Neuromodulation, reported 2023-11-08, distributed in FL, MO, TX, WA. There are a small number of units of the DBS Lead with StimLoc kit (3387S-40) due to a discrepancy in the Use
| Recall number | Z-0217-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2022-05-27 |
| Classified | 2023-11-02 |
| Reported by FDA | 2023-11-08 |
| Distributed | FL, MO, TX, WA |
| Quantity | 14 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00763000274320 |
| Serial numbers | VA2JV2V |
| Model numbers | 3387S-40 |
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Reason for recall
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.
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-0217-2024. 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.