Medtronic Neuromodulation LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Brand
Medtronic Neuromodulation
Lot Codes / Batch Numbers
UDI/DI 00763000274320, Serial Number VA2JV2V
Products Sold
UDI/DI 00763000274320, Serial Number VA2JV2V
Medtronic Neuromodulation is recalling LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. due to 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 packa. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, MO, TX, WA
Page updated: Jan 10, 2026