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Medtronic Neuromodulation recalls Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Recalled May 27, 2015 · FDA recall Z-1617-2015 · Medtronic Neuromodulation
Hazard
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). · FDA Class II
Units
86,851 (US 37,933 / OUS 48,918)
Sold at
worldwide
Description
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).
Product
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →