Boston Scientific's Imager II catheter recall classified as FDA Class I
U.S. FDA said Boston Scientific reported two serious injuries and no deaths from the device defect, and the company decided to discontinue selling the product line.
S. FDA classifies Boston Scientific Corp's Imager II angiographic catheter recall as Class I, the most serious type, because of injury risk. The FDA said Boston Scientific reported two serious injuries and no deaths tied to the Imager II catheter defect. The company has also decided to discontinue selling the Imager II angiographic catheter product line.