Reported Nov 8, 2023 · Completed
LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
Medtronic Neuromodulation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568
Is this the product you have?
- LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
- Lot codes and dates
UDI/DI 00763000274320Serial Number VA2JV2V
- Amount recalled
- 14 units
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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