FDA Flags Problem with Boston Scientific Percutaneous Catheters

The FDA issued an Early Alert about a letter Boston Scientific sent July 9, which advised that some of its Enroute transcarotid neuroprotection percutaneous catheters be removed from use or sale.

The specific lots of Enroute and Enroute Plus catheters are being removed following reports of total or partial separation of the arterial sheath during use. If the tip separates, endovascular or surgical retrieval may be necessary for the retained tip. This runs the risk of embolism, stroke, transient ischemic attack, restenosis, or thrombosis.

Boston Scientific reported as of July 9, there has been one serious injury and no deaths related to this issue. The company told customers to immediately stop further use and distribution, and return the product immediately.

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.

Boston Scientific acquired the system in its $1.16 billion transaction for Silk Road Medical in 2024.