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Medtronic Neuromodulation recalls LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Recalled November 8, 2023 · FDA recall Z-0217-2024 · Medtronic Neuromodulation
Hazard
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 Class II
Units
14 units
Sold at
US: MO, FL, TX, WA
Description
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.
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →