FDA-Device2021-03-03Class II
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Silk Road Medical Inc
Hazard
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Sold states
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
Affected count
Total = 455 systems
Manufactured in
1213 Innsbruck Dr, N/A, Sunnyvale, CA, United States
Products
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2021Don't want to check this manually?
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