BEUDAMED
    FDA Recall Terminated

    ENROUTE Transcarotid Stent System REF SR-XXYY-CS

    Recall: Z-1146-2021 · Initiated January 13, 2021

    Recall

    Recall Number
    Z-1146-2021
    Event Number
    87196
    Firm
    Silk Road Medical Inc
    FEI Number
    3007215228
    Product Code
    NIM
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 13, 2021
    Terminated
    January 31, 2023
    Address
    1213 Innsbruck Dr, Sunnyvale, CA, 94089-1317

    Description

    ENROUTE Transcarotid Stent System REF SR-XXYY-CS

    Reason

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

    Action

    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]

    Distribution

    U.S.: AZ, CA, CO, CT, DC, DE, FL, GA, HI, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: None

    Quantity

    Total = 455 systems