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Completed

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

FDA Recall Z-0217-2024 · Posted 2023-11-03

Recalling FirmMedtronic Neuromodulation
Recall StatusCompleted
Product CodeMHY
Date Initiated2022-05-27
Product Quantity14 units

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.

Firm 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.

Root Cause

Labeling Change Control

Distribution Pattern

US: MO, FL, TX, WA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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