LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
FDA device recall Z-0217-2024 · posted 2023-11-03 · Completed
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Completed
- Product code
- MHY
- Quantity affected
- 14 units
- Distribution
- US: MO, FL, TX, WA
- Date initiated
- 2022-05-27
- Date posted
- 2023-11-03
- Location
- Minneapolis, MN
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