Recall Z-0217-2024
Medtronic Neuromodulation · initiated May 27, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Codes / lots: UDI/DI 00763000274320, Serial Number VA2JV2V
Reason for recall
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.
FDA-determined cause: Labeling Change Control
Action taken
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.
Details
- Recall number
- Z-0217-2024
- Initiated
- May 27, 2022
- Posted by FDA
- November 3, 2023
- Product code
- MHY – Stimulator, Electrical, Implanted, For Parkinsonian Tremor
- Quantity
- 14 units
- Distribution
- US: MO, FL, TX, WA
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN