Reported Mar 3, 2021 · Terminated
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Silk Road Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Silk Road Medical Inc · 1213 Innsbruck Dr · Sunnyvale, CA · 94089-1317
Is this the product you have?
- ENROUTE Transcarotid Stent System REF SR-XXYY-CS
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published SR0930CS00811311020492Lot Number: 17917092 UDI Code: (01)00811311020492(17)211231(10)17923717 SR1030CS00811311020522Lot Number: 17923717 UDI Code: (01)00811311020522(17)220131(10)17929776 SR1040CS00811311020539Lot Number: 17929776 UDI Code: (01)00811311020539(17)220131(10)17931107 SR0940CS00811311020508Lot Number: 17931107 UDI Code: (01)00811311020508(17)230131(10)301576 — Lot Number: 301576 - Amount recalled
- Total = 455 systems
Where it was sold
Why it was recalled
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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