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Medtronic Neuromodulation recalls Medtronic, Activa PC, Model 37601, Method of Sterilization: Ethylene Oxide, Single Use Only, Rx Only. The Activa¿ PC
Recalled August 27, 2014 · FDA recall Z-2259-2014 · Medtronic Neuromodulation
Hazard
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing. · FDA Class II
Units
6
Sold at
Distributed in the states of: MA, NC, OH, and TX.
Description
Medtronic is recalling six Activa PC (model 37601) Implantable Neurostimulators due to the potential for a damaged electrical component during manufacturing.
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.
Manufacturer(s)
Medtronic Neuromodulation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →