ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

On 01/13/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via email to customers informing them that product complaints have been received where the tip/nose cone detached from the stent delivery system during use and it is possible the resulting patient harm can range from minor intervention required to retrieve the detached tip/nose cone to embolization or stroke if the device failure goes undetected. Customers are instructed to: 1. Immediately removed the affected lots from hospital inventory and quarantine the products in a secure location until such time as the Recalling Firm can arrange for removal from their facility. The affected units will be permanently removed from commercial distribution. There is no need for action related to devices already used during a procedure. 2. Immediately upon receipt of the email notification, reply to the email to [email protected] and record the number of units for each affected lot 3. If not impacted products remain in their facility or a Recalling Firm's field representative has already removed the affected products, customer are to indicated this accordingly on the email reply. For any questions, contact the Recalling Firm at 855-410-8227 ext. 2110 Monday through Friday 8:00 a.m. to 5:00 p.m. Pacific Time or email [email protected]