Class 2 Device Recall Stimulator, electrical, implantable device.

• Date Initiated by Firm: May 27, 2022
• Date Posted: November 03, 2023
• Recall Status: Completed
• Recall Number: Z-0217-2024
• Recall Event ID: 93170
• PMA Number: P960009
• Product Classification: Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
• Product: LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Code Information: UDI/DI 00763000274320, Serial Number VA2JV2V
• FEI Number: 2182207
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave Ne; Minneapolis MN 55432-3568
• For Additional Information Contact: Medtronic Customer Service; 800-962-9888
• Manufacturer 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.
• FDA Determined Cause: Labeling Change Control
• Action: 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.
• Quantity in Commerce: 14 units
• Distribution: US: MO, FL, TX, WA
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.

• PMA Database: PMAs with Product Code = MHY