Interventional technology developer Boston Scientific has recalled its iCross and Atlantis SR Pro2 coronary imaging catheters.
The tips of these catheters can break inside of the patient and embolize, causing tissue and blood vessel injury, heart attack, or other serious events requiring additional unplanned surgery, according to the U.S. Food and Drug Administration (FDA). Boston Scientific notified customers by letter on May 27 and instructed them to discontinue use and return all products to the firm.
