FDAFDA · Food and drugs·Recall number Z-2259-2014
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.
Published August 27, 2014 · Recall initiated: July 14, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- Medtronic Neuromodulation
- Distributor
- Distributed in the states of: MA, NC, OH, and TX.
- Lot
- Serial numbers: NKM724776H, NKM724782H, NKM724785H, NKM724790H, NKM724802H, NKM724843H.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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