Electrodes Used to Treat Epilepsy Recalled Due to Risk of Scraping Brain Tissue and Leaving Broken Pieces of the Device in the Brain upon Removal
The U.S. Food & Drug Administration has announced that Ad-Tech is recalling 115 Macro Micro Subdural Electrodes used on patients with epilepsy to record, monitor, and stimulate electrical signals on the surface of the brain. On December 18, 2012, Ad-Tech issued an Urgent Medical Device Recall to doctors and hospitals telling them to stop using the recalled lots immediately. This urgent recall of these devices, manufactured from June 2006 to March 2012, stems from concern that the microelectrodes may be defective and scrape brain tissue when removed by a physician. There is further concern that the microelectrodes may break during explantation, leaving pieces of the device behind in the brain tissue. These events may lead to hemorrhaging, seizure, and/or death. The FDA reports at least one serious injury that may have been related to the use of Ad-Tech’s device.
FDA Safety Alert for Ad-Tech Macro Micro Subdural Electrodes 03/07/13
FDA Class I Recall Notice for Ad-Tech Macro Micro Subdural Electrodes 12/18/12
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