MASSDEVICE ON CALL — Federal healthcare regulators gave Ad-Tech Medical Instrument Corp.’s wide-reaching brain implant recall Class I status, the highest-risk category for medical device recalls.
Late last year the Wisconsin-based medical device maker recalled 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, and Ad-Tech has received at least 1 report of serious injury that may have been related to use of the device, according to a prior FDA notice.
"There is a concern the microelectrodes are defective and may cause injury to the brain," the FDA reported this week. "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."
The FDA gave the recall Class I status, a designation reserved for measures in which "there is a reasonable probability that use of these products will cause serious adverse health consequences or death," according to the federal watchdog agency.
The electrodes in question 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 reported.
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