DBS Lead Device Recall: Use By Date Label Discrepancy
Medtronic is recalling a small number of LEAD 3387S-40 deep brain stimulation devices due to discrepancies in the Use By Date printed on the outer package versus the individual product label.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy rather than reported safety incidents. No illnesses, injuries, or device failures have been reported. The issue represents a minor labeling error affecting a small number of units.
Plain-English summary
Medtronic Neuromodulation is recalling a small number of units of the LEAD 3387S-40 STIMLOC DBS device, an electrical implantable device.
The recall is 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. This discrepancy may create confusion about the correct shelf life for the device.
The affected devices were distributed in Missouri, Florida, Texas, and Washington. Patients and healthcare providers who have received or are considering these devices should contact Medtronic Neuromodulation to address the discrepancy.
The recalled product
- Product
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Manufacturer
- Medtronic Neuromodulation
- Hazard
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 00763000274320
- Serial Number VA2JV2V
Distribution
Related recalls
Same manufacturer · Medtronic Neuromodulation
See all →- ModerateMedtronic 1x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- ModerateMedtronic 2x4 pocket adaptor kits carry incorrect use-by dates
FDA (Devices) · 2026-06-03
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateNeurostimulator clinician programmer app recalled over faults during device use
FDA (Devices) · 2026-01-21
- HighFemoral nails, 360 mm left trochanteric, recalled over undersized shaft diameter
FDA (Devices) · 2025-12-31
Same hazard · labeling error
See all →- ModerateLiquid Hope Organic Meal Replacement Formula Subpotent Vitamin A Recall
FDA (Food) · 2026-07-22
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- Moderate
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighAdndale magnesium glycinate gummies contain undeclared melatonin in three lots
FDA (Food) · 2026-06-24