A recall has been issued for Ad-Tech Medical Instrument Corporation’s Macro Micro Subdural Electrodes, due to a potential risk that the device may cause damage to brain tissue and the electrodes may fracture.
The Ad-Tech subdural electrode recall was initiated late last year and posted on the FDA’s website this week, indicating that at least one report involving serious injury to a patients brain has been identified involving problems with the electrodes.
According to Ad-Tech’s press release, the micro electrodes are not flush with the silastic surface. This may lead to the electrodes causing abrasion to the tissue of the brain and may even result in the fracture of the electrodes, leaving pieces of the electrode in the brain when the devices are removed. This could cause patients to hemorrhage, suffer seizures, strokes, damage the brain’s cortical fibers and other brain complications.
The electrodes are used in temporary situations with recording, monitoring and stimulation equipment for recording, monitoring and stimulation of electrical signals on the surface level of the brain.
The recall affects a total of 155 Macro Micro Subdural Electrodes that were manufactured between June 2006 and March 2012. The electrodes were then distributed to hospitals and other distribution companies in the United States and internationally between June 8 and March 14. A full list of catalog numbers, lot numbers and batch numbers is in the recall notice. The affected units can be identified by matching these to the label on the packaging.
Ad-Tech notified hospitals and distributors with a recall letter and will arrange for all electrodes to be returned to the Racine, WI based company. They advise all customers to stop use the product. Customers with questions can contact Ad-Tech at 800-776-1555 or send an e-mail to [email protected]