FDAJune 10, 2016device
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
What to do
FDA enforcement status: Terminated
Brands named
medtronic neuromodulationmedtronic
Recall history
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