FDAApril 16, 2015device
Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Official recall recorded by the U.S. Food & Drug Administration.
The 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).
What to do
FDA enforcement status: Terminated
Brands named
medtronic neuromodulationmedtronic
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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