Neurological devices maker Ad-Tech Medical Instrument Corp. recalls nearly 6 years' worth of subdural electrodes over concerns that they may cause brain damage.
Wisconsin-based medical device maker Ad-Tech Medical Instrument Corp. launched a wide-reaching recall of its Macro Micro Subdural Electrodes over concerns that the implanted devices could cause damage to the brain.
The recall extends to devices manufactured from June 2006 to March 2012, according to an FDA notice.
"There is a concern the micro-electrodes are not flush with the silastic surface," the company reported to the FDA. "As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity."
Ad-Tech has received at least 1 report of serious injury that may have been related to use of the device, according to the notice.
The company launched the recall late last year, and is asking all distributors and customers to return available recalled products. The affected electrodes were distributed in the U.S. and internationally, Ad-Tech noted.
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