FDA Recalls Defective Medical Device
March 11, 2013
The U.S. Food and Drug Administration (FDA) and medical device manufacturer, Ad-Tech Medical Instrument Corporation, have announced the voluntary recall of 115 units of Macro Micro Subdural Electrodes. An FDA press release indicated the recall was issued due to manufacturing defects that could lead to the serious injury or death of a patient.
The products were manufactured and distributed from 2006 to 2012 and are used to record deep brain structures. The recall was issued after reports were received of the microelectrodes not being properly fastened to the silastic surface of the device. This can potentially result in scraping or cutting of cortical brain tissue, or fragments in the brain when the device is removed.
Injuries that may result from the recalled electrodes include:
- hemorrhaging of the brain,
- infection of the brain
- brain infarction
- and death.
One injury has been reported in connection with the Defective Medical Device.
Ad-Tech is contacting both distributors and consumers of the product via mail regarding the recall and how to return all affected products. If any person experiences an adverse health event due to use of the device, they are being asked to report the incident to the FDA.
The Denver Personal Injury Lawyers with the McDivitt Law Firm would advise defective medical device injury victims to discuss their cases with experienced attorneys to protect their legal rights to compensation.Back to the Blog