Boston Scientific ENROUTE Transcarotid System Removal Classified as Class I Recall

The FDA has classified Boston Scientific's removal of specific lots of its ENROUTE Transcarotid Neuroprotection System and ENROUTE Transcarotid Neuroprotection System Plus as a Class I recall, the agency's most serious category, according to entries posted to its medical device recall database on August 20.

The two database entries (recall numbers Z-2977-2026 and Z-2978-2026) list the manufacturer's reason for recall as the "Potential for arterial sheath tip separation or partial tip separation during use." They cover 115,458 units of the standard system and 49,229 units of the Plus version, distributed across the US and to Australia, Canada, China and Jamaica. The FDA's determined cause is listed as under investigation by the firm.

What the FDA notice says

The FDA first posted the problem on July 24 as an early alert, which its notice describes as a communication to notify the public of a potentially high-risk device issue. According to the agency's recall notice, a separated tip may require endovascular or surgical retrieval, and complications associated with a retained tip include embolism, stroke, transient ischemic attack, restenosis or thrombosis.

"As of July 9, Boston Scientific has reported one serious injury and no deaths associated with this issue," the notice says.

The ENROUTE system is used during transcarotid artery procedures. The FDA notice says it is designed to carry emboli away from the carotid circulation by reversing blood flow at the treatment site before a lesion in the carotid artery is crossed and while it is manipulated. The FDA notes that the devices may appear under the name Silk Road Medical in hospital inventory systems The database lists Boston Scientific Corporation in Maple Grove, Minnesota, as the recalling firm.

Actions requested of customers

Boston Scientific sent an "Urgent Medical Device Removal" notice to customers on July 9, according to the database entries. The company asked customers to:

• Immediately stop using and distributing affected product and set it aside.
• Complete and return a reply verification form to receive a return authorization number, even if they have no affected product.
• Return affected product to Boston Scientific for credit.
• Forward the notice to relevant staff and to any facility that received the devices.

The FDA notice tells facilities not to use affected product. The lot numbers are listed in the database entries. The recall applies to the 510(k)-cleared systems K153485 (standard) and K230402 (Plus), both under product code NTE for temporary carotid catheters for embolic capture.

Customers with questions can reach Boston Scientific at BSCFieldActionCenter@bsci.com or (763) 415-7708, according to the FDA notice. The database lists the recall as open, meaning not all affected products have been corrected or removed.