Medtronic Neuromodulation Recall 93170
Description: LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Medtronic Neuromodulation Recall 93170 Information
Status | Completed |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0217-2024 |
Event ID | 93170 |
Event Description | LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device. |
Product Type | Devices |
Distribution | US: MO, FL, TX, WA |
Quantity | 14 units |
Recall 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. |
Device Classification | 20231108 |
Device Code Info | UDI/DI 00763000274320, Serial Number VA2JV2V |
Center Classification Date | 20231102 |
Recall Initiation Date | 20220527 |
Recalling Firm | Medtronic Neuromodulation |
Initial Notification | Letter |
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