FDA recalls brain scanning device citing potential for deadly error
The U.S. Food and Drug Administration has issued its most serious type of recall for an imaging device that surgeons rely on during deep brain stimulation procedures, according to a Monday announcement.
In handing down the class 1 recall, federal officials warn that using such devices may cause serious injuries or death.
Medtronic’s StealthStation auto-registration feature provides images of a patient’s brain to help surgeons navigate tools and implants used during deep brain stimulation. During DBS a surgeon uses a neurostimulator to deliver electrical signals to areas of the brain that control movement, pain, mood, weight and other functions.
“Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process when used with NexFrame during a DBS procedure, which may not be detected by the surgeon or the device system,” the FDA posted on its website. “This may provide inaccurate registration data which could lead surgeons to inaccurately navigate lead placement during image guided DBS procedures.”
As of June 1, 33 medical device reports have been identified, including 22 device malfunctions and 11 related to injuries.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.