Ad-Tech Macro Micro Subdural Electrodes: Class 1 Recall
MedSun: Newsletter #82, March 2013
FDA MedWatch Safety Alert
FDA and Ad-Tech notified healthcare professionals of a Class 1 recall due to concern the microelectrodes are defective and may cause injury to the brain. These devices 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. There is the potential for abrasion of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the electrode.
Ad-Tech Macro Micro Subdural Electrodes: Class 1 Recall. March 7, 2013.