—#203595

Product

LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.

FDA product code: MHY — Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P960009
Affected lot / code info: UDI/DI 00763000274320, Serial Number VA2JV2V

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

Medtronic issued a Medical Device Removal notice to its consignees on 05/27/2023 by US mail. The notice explained the issue, potential risk, and requested the return of the affected product.

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave Ne, Minneapolis, Minnesota 55432-3568

Distribution

Distribution pattern: US: MO, FL, TX, WA

Timeline

Recall initiated: 2022-05-27
Posted by FDA: 2023-11-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203595. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.