Medtronic Neuromodulation recalls Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

Recall date

June 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2602-2016

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).