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Recall Observatory FDA recall evidence

Device product

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

Z-1617-2015

April 16, 2015

Class II

Product summary

Firm
Medtronic Neuromodulation
Event
Event 71016
Status
Terminated
Classification
Class II
Quantity
86,851 (US 37,933 / OUS 48,918)
Official record key
device-enforcement:Z-1617-2015

Official wording

Reason: 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).

Code information: all Serial numbers

Distribution pattern: worldwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).