RecallDepth

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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