Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ENROUTE Transcarotid Stent System REF SR-XXYY-CS Recalled by Silk Road Medical Inc Due to Due to complaints received that the tip/nose cone...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Silk Road Medical Inc directly.
Affected Products
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Quantity: Total = 455 systems
Why Was This Recalled?
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Where Was This Sold?
This product was distributed to 43 states: AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WV, WI, DC
About Silk Road Medical Inc
Silk Road Medical Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report