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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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