FDA Issues Early Alert for Boston Scientific ENROUTE System Recall

Boston Scientific is recalling specific lots of its ENROUTE Transcarotid Neuroprotection System and System Plus due to reports of arterial sheath tip separation during use, prompting an Early Alert from the U.S. Food and Drug Administration (FDA).

This issue may necessitate endovascular or surgical retrieval of the separated tip, with potential complications including embolism, stroke, transient ischemic attack, restenosis, or thrombosis. As of July 9, one serious injury has been reported in connection with this problem, though no deaths have occurred.

"CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue," the FDA said, adding, "The FDA will keep the public informed and update this web page as significant new information becomes available." Customers with questions or adverse reactions should contact Boston Scientific at BSCFieldActionCenter@bsci.com or call (763) 415-7708.