The U.S. Food and Drug Administration (FDA) has designated Ad-Tech Medical Instrument Corporation’s recall of its Macro Micro Subdural Electrode brain implant a Class I recall, the highest-risk category for medical device recalls.
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 said, according to MassDevice.com. In describing the reasons for the recall, the FDA writes, “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 Wisconsin-based medical device manufacturer, initiated the recall in 2012 for devices manufactured from June 2006 to March 2012, MassDevice.com reports. In a February 28 press release posted on the FDA web site, the firm said, “There has been one reported serious injury that may have been related to the use of the device.”
According to the FDA, it reserves Class I recall status for situations in which “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
The recall notice advises customers to return all recalled products to the firm and, if the electrodes have been further distributed, to notify subsequent purchasers of the recall. Health-care professionals and patients can report adverse events to the FDA under its MedWatch Adverse Event Reporting Program online, by regular mail, or by fax through www.fda.gov/Safety/MedWatch/HowToReport/default.htm.