Recall archive / FDA device enforcement
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. — FDA record Z-0217-2024
Reported completed
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 27, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 14 units
- Agency-reported status
- Completed
- Source record identifier
- Z-0217-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI 00763000274320, Serial Number VA2JV2V |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: MO, FL, TX, WA
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Nov 8, 2023
- Recall initiation date
- May 27, 2022
- Center classification date
- Nov 2, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.