Medtronic — Class II medical device recall Z-2259-2014
Terminated recall by Medtronic Neuromodulation, reported 2014-08-27, distributed in MA, NC, OH, TX. Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a dam
| Recall number | Z-2259-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2014-07-14 |
| Classified | 2014-08-18 |
| Reported by FDA | 2014-08-27 |
| Terminated | 2014-10-06 |
| Distributed | MA, NC, OH, TX |
| Quantity | 6 |
| Serial numbers | NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H |
| Model numbers | 37601 |
Product
Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC neurostimulator is a dual-channel device capable of delivering bilateral stimulation. Activa PC contains a non-rechargeable battery and microelectronic circuitry to deliver a controlled electrical pulse to precisely targeted areas of the brain. The device is typically implanted subcutaneously near the clavicle, connected to an extension and leads, which are implanted in the brain.
Reason for recall
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
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.