Boston Scientific ENROUTE System Recall is Class 1

FDA says the Boston Scientific 7/9 recall of its ENROUTE Transcarotid Neuroprotection System is Class 1. An agency notice says the company notified customers that the affected devices should be removed from where they are used or sold.

The ENROUTE Transcarotid System reportedly is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site before crossing a lesion in the carotid artery and during lesion manipulation.

Boston Scientific said the recall followed reports of arterial sheath separation or partial tip separation during use. “Tip separation may require endovascular or surgical retrieval of the retained tip,” FDA says. “Complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis, or thrombosis.” As of 7/9, the company reported one serious injury and no deaths associated with the issue.