The U.S. Food and Drug Administration issued an early alert regarding a potentially high-risk issue with certain percutaneous catheters manufactured by Boston Scientific (NYSE: BSX), specifically the ENROUTE Transcarotid Neuroprotection System (NPS) and ENROUTE Transcarotid Neuroprotection System Plus (NPS Plus).

Boston Scientific initiated the removal of specific lots of the devices due to reports of arterial sheath tip separation or partial tip separation during use. Tip separation may require endovascular or surgical retrieval of the retained tip, with potential complications including embolism, stroke, transient ischemic attack, restenosis, or thrombosis.

As of July 9, Boston Scientific reported one serious injury and no deaths associated with the issue.

On July 9, Boston Scientific sent letters to affected customers instructing them to immediately stop use and distribution of the affected product, segregate and return it to Boston Scientific, and notify relevant personnel. Facilities that forwarded the devices to other locations were instructed to contact those facilities with the notice.

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

The FDA stated it is continuing to review information related to the issue and will provide updates as new information becomes available.