FDA-Device2016-08-31Class II
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Medtronic Neuromodulation
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.
Sold states
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
Affected count
70
Manufactured in
7000 Central Ave, Minneapolis, MN, United States
Products
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2602-2016Don't want to check this manually?
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