Silk Road Medical ENROUTE Transcarotid Stent System REF SR-XXYY-CS recall — FDA Z-1146-2021
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Overview of recall records associated with Silk Road Medical Inc., including dates, categories and classifications where available.
Classification mix: Class II: 1.
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
This page summarizes recall records in which the official source identifies Silk Road Medical Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.