Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0217-2024 — LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

U.S. FDA — Device Enforcement · United States · 2022-05-27 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0217-2024
Date of alert
2022-05-27
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medtronic Neuromodulation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00763000274320
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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