LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Company
- Medtronic Neuromodulation
- Recall Initiated
- May 27, 2022
- Posted
- November 3, 2023
- Recall Number
- Z-0217-2024
- Quantity
- 14 units
- Firm Location
- Minneapolis, MN
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.
Distribution
US: MO, FL, TX, WA
Lot / Code Info
UDI/DI 00763000274320, Serial Number VA2JV2V
Root Cause
Labeling Change Control
Action Taken
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.
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