San Jose Business Journal -- A device designed by Arstasis Inc. has been recalled by the Food and Drug Administration over fears that it could break during use.
Redwood City-based Arstasis makes the device to access the femoral artery during catheterization procedures.
In a Class I recall notice -- the most serious type of recall -- the FDA said the system may fracture and/or separate during use, which may result in patient harm.
The company is led by founder and CEO D. Bruce Modessit.
