Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Medtronic Activa PC Recalled by Medtronic Neuromodulation Due to Medtronic notified customers regarding over stimulation or stimulation...
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 Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs)
Quantity: 38,294
Why Was This Recalled?
Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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