Medtronic Activa PC — Class II medical device recall Z-0125-2014
Terminated recall by Medtronic Neuromodulation, reported 2013-11-06, distributed nationwide. Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Med
| Recall number | Z-0125-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2013-09-30 |
| Classified | 2013-10-31 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2015-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AW, BE, BG, BR, CH, CL, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, HR, HU, IE, IL, IN, IQ, IR, IS, IT, JO, JP, KW, LB, LT, LU, LV, MA, MT, MX, NL, NO, OM, PA, PE, PK, PL, PT, QA, RO, RS, SA, SE, SI, SK, SV, TN, TR, UA, UY, VE, ZA |
| Quantity | 38,294 |
| Model numbers | 37601, 37612 |
Product
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)
Reason for recall
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.