Home / Recalls / Medical Devices
Silk Road Medical Inc recalls ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Recalled March 3, 2021 · FDA recall Z-1146-2021 · Silk Road Medical
Hazard
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. · FDA Class II
Units
Total = 455 systems
Sold at
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
Description
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Product
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Manufacturer(s)
Silk Road Medical Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →