The U.S. Food and Drug Administration (FDA) has given a Class I designation to the recall of Ad-Tech Medical Instrument Corporation’s Macro Micro Subdural Electrode brain implant. This is the agency’s highest-risk category for a medical device recall.
The FDA reserves Class I status for situations in which “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recalled electrodes are intended for temporary use in patients with epilepsy and are designed for recording, monitoring, and stimulation of electrical signals on the surface of the brain, the FDA explained. “There is a concern the microelectrodes are defective and may cause injury to the brain. As a result, there is the potential for scraping (abrasion) of brain tissue and for broken pieces to remain in the brain tissue when the physician removes the electrode. This may lead to hemorrhaging or a seizure, as well as death.”
Ad-Tech, a medical device manufacturer based in Racine, Wisconsin, initiated the recall in December 2012, for devices manufactured from June 2006 to March 2012, MassDevice.com reports. In a firm press release posted on the FDA web site, Ad-Tech acknowledges “one reported serious injury that may have been related to the use of the device.”
Ad-Tech and the FDA have advised customers to return all recalled Macro Micro Subdural Electrodes to the firm, and, if the electrodes have been further distributed, to notify subsequent purchasers of the recall. Customers with questions may call the company at 1.800.776.1555 between 9:00 a.m. and 5:00 p.m. (Central Time), or contact the company by e-mail at firstname.lastname@example.org.
Doctors and patients can report adverse events to the FDA under its MedWatch Adverse Event Reporting Program online, by regular mail, or by fax. Go to www.fda.gov/medwatch/report.htm.