Z-2259-2014 Class II Terminated
FDA device recall Z-2259-2014 was initiated by Medtronic Neuromodulation on Jul 14, 2014 and is designated Class II. Reason for recall: Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. The recall status is terminated (terminated Oct 6, 2014). Affected quantity: 6.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 27, 2014
- Initiation Date
- Jul 14, 2014
- Termination Date
- Oct 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6
Product Description
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.
Distribution Pattern
Distributed in the states of: MA, NC, OH, and TX.
Code Information
Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2259-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026