Silk Road Medical recalls ENROUTE Transcarotid Stent System REF SR-XXYY-CS due to tip detachment complaints. Affected units have specific catalog and lot numbers. Contact for remedy.
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Silk Road Medical is recalling its ENROUTE Transcarotid Stent System (model SR-XXYY-CS) because the tip/nose cone may detach during use. This could lead to serious complications if the stent moves incorrectly in the body.
The tip/nose cone of the stent system can detach during use, potentially causing the device to move incorrectly in the body. This could lead to serious complications such as bleeding or damage to nearby tissues.
Patients who have received the ENROUTE Transcarotid Stent System (model SR-XXYY-CS) from Silk Road Medical are most at risk. Healthcare providers using the device for procedures may also be affected.
Check for the catalog number SR0930CS, SR1030CS, SR1040CS, or SR0940CS with specific lot numbers listed in the recall notice. The device is sold under the brand Silk Road Medical.
Review the catalog number and lot number on your device to confirm if it is affected.
The recall states that the tip may detach, so it is not safe to use without checking if it is affected.
The recall does not specify a remedy, so contact Silk Road Medical for further instructions.
Check for catalog numbers SR0930CS, SR1030CS, SR1040CS, or SR0940CS with the listed lot numbers.
We’ve drafted a message you can send Silk Road Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1146-2021 — Silk Road Medical Silk Road Medical Hello, I own a Silk Road Medical that is covered by recall Z-1146-2021 from Silk Road Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
