BEUDAMED
    FDA Enforcement Class II Terminated

    ENROUTE Transcarotid Stent System REF SR-XXYY-CS

    Recall: Z-1146-2021 · Reported March 3, 2021

    Enforcement

    Recall Number
    Z-1146-2021
    Event ID
    87196
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Silk Road Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 3, 2021
    Initiation Date
    January 13, 2021
    Classification Date
    February 23, 2021
    Termination Date
    January 31, 2023
    Address
    1213 Innsbruck Dr, N/A, Sunnyvale, CA, 94089-1317, United States

    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.

    Code Info

    Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211130(10)17917092 Lot Number: 17917092 Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211231(10)17923717 Lot Number: 17923717 Catalog Number: SR1030CS UDI Code: (01)00811311020522(17)220131(10)17929776 Lot Number: 17929776 Catalog Number: SR1040CS UDI Code: (01)00811311020539(17)220131(10)17931107 Lot Number: 17931107 Catalog Number: SR0940CS UDI Code: (01)00811311020508(17)230131(10)301576 Lot Number: 301576

    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