FDA Device recall Z-0279-2014
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603
- FDA Device
- Class II
- terminated
- Published 2013-11-20
On 2013-11-20 the FDA classified a Class II recall of Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603 by Medtronic Neuromodulation, citing medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multipl….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0279-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-30 |
| Published | 2013-11-20 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
Product
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
Reason
Medtronic notified customers regarding Loss of Stimulation of specific Implantable Neuro-Stimulators under the following specific conditions: Switching between groups with Multiple programs or creating program groups. Therapy can be restored with the Physician Recharge mode (RPM) of the Implantable Neurostimulator Recharger (INSR).
Identifiers
| code_info | all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0279-2014%22
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