Medtronic Neuromodulation recalls Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

Recall date

April 16, 2015

Source

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

Recall number

Z-1617-2015

FDA classification

Class II

Brand / firm

Medtronic Neuromodulation

Sold / distributed

worldwide

Why it was recalled

Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa¿ PC (Model 37601), Activa¿ RC (Model 37612), and the Activa¿ SC (Model 37603).

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 DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile