Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Medtronic DBS Extension Kit for Deep Brain Stimulation Recalled by Medtronic Neuromodulation Due to Medtronic is providing Important information regarding extension handling...

Date: April 16, 2015
Company: Medtronic Neuromodulation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Neuromodulation directly.

Affected Products

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

Quantity: 86,851 (US 37,933 / OUS 48,918)

Why Was This 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).

Where Was This Sold?

worldwide

About Medtronic Neuromodulation

Medtronic Neuromodulation has 95 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report