Use caution Medical device recall · FDA · Published January 13, 2021

Silk Road Medical ENROUTE Transcarotid Stent System Recall: Tip May Detach

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1146-2021Medical device Silk Road Medical ›

Use caution until it’s fixed

Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.

Take action

Contact the company

Recalling firmSilk Road Medical Inc1213 Innsbruck Dr · Sunnyvale, CA 94089-1317

✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/63429-silk-road-medical-enroute-transcarotid-stent-system-recall-tip-may.

Source Summary by GovInfoNow · govinfonow.com/recall/63429-silk-road-medical-enroute-transcarotid-stent-system-recall-tip-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1146-2021

Cite this page

“Silk Road Medical ENROUTE Transcarotid Stent System Recall: Tip May Detach.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63429-silk-road-medical-enroute-transcarotid-stent-system-recall-tip-may. Based on FDA recall #Z-1146-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2021%22&limit=1).

Silk Road Medical Inc recalled the ENROUTE Transcarotid Stent System REF SR-XXYY-CS due to a potential tip detachment hazard, according to the FDA on Jan. 13, 2021.

How to tell if you have it

ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Catalog Number: SR0930CS, Lot Number: 17917092, UDI Code: (01)00811311020492(17)211130(10)17917092
Catalog Number: SR0930CS, Lot Number: 17923717, UDI Code: (01)00811311020492(17)211231(10)17923717
Catalog Number: SR1030CS, Lot Number: 17929776, UDI Code: (01)00811311020522(17)220131(10)17929776
Catalog Number: SR1040CS, Lot Number: 17931107, UDI Code: (01)00811311020539(17)220131(10)17931107
Catalog Number: SR0940CS, Lot Number: 301576, UDI Code: (01)00811311020508(17)230131(10)301576
UPC 00811311020492
UPC 00811311020508
UPC 00811311020522
UPC 00811311020539

The hazard

The recall addresses complaints that the tip or nose cone may detach from the Transcarotid Stent System.

Context

GovInfoNow's records show other recent recalls of similar products include Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (2026-07-09) and Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus: Risk of Arterial Sheath Tip Separation (2026-07-09). CGuard Prime Carotid Stent System Recall: Deployment Complications Risk occurred on 2026-05-01.

How to tell if you have this one

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.

Brand
Silk Road Medical
Product
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Review the catalog number and lot number on your device to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed in 42 states and D.C..

FDA distribution: “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” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

Jan 13, 2021Firm started the recall
Feb 23, 2021FDA classified it Class II
Mar 3, 2021Published in FDA’s Enforcement Report
Jan 31, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this device safe to use?

The recall states that the tip may detach, so it is not safe to use without checking if it is affected.

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Keep exploring

More Silk Road Medical recalls

Link to this recall

<a href="https://govinfonow.com/recall/63429-silk-road-medical-enroute-transcarotid-stent-system-recall-tip-may">Silk Road Medical ENROUTE Transcarotid Stent System Recall: Tip May Detach (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1146-2021 (January 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1146-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.