Recall Z-0217-2024 ยท MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Medtronic Neuromodulation
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
| Date | Nov 3, 2023 (initiated May 27, 2022) |
| Status | Completed |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 14 units |
| Distribution | US: MO, FL, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.