Lead 3387s-40 Stimloc DBS recall
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Why was Lead 3387s-40 Stimloc DBS 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 00763000274320, Serial Number VA2JV2V
- Product
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 14 units
- Distribution
- US: MO, FL, TX, WA
- Recall date
- November 8, 2023
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)