Macro Micro Subdural Electrodes are the subject of a Class I recall. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity.
Macro Micro Subdural Electrodes are intended for temporary (less than 30 days) use on patients with epilepsy for the recording, monitoring and stimulation of electrical signals on the surface level of the brain.
Ad-Tech Medical Instrument Corporation voluntarily recalled the Macro Micro Subdural Electrodes after becoming aware of one reported serious injury that may have been related to the use of the device. The recalled products were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.
The FDA has classified this recall as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall