Silk Road Medical Inc recalls ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Recall date

January 13, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1146-2021

FDA classification

Class II

Brand / firm

Silk Road Medical Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

ENROUTE Transcarotid Stent System REF SR-XXYY-CS