ENROUTE Transcarotid Stent System REF SR-XXYY-CS — Class II medical device recall Z-1146-2021
Terminated recall by Silk Road Medical Inc, reported 2021-03-03, distributed in AZ, CA, CO, CT, DC, DE, FL, GA…. Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
| Recall number | Z-1146-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Silk Road Medical Inc, Sunnyvale, CA, United States |
| Recall initiated | 2021-01-13 |
| Classified | 2021-02-23 |
| Reported by FDA | 2021-03-03 |
| Terminated | 2023-01-31 |
| Distributed | 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, WV |
| Quantity | 455 systems |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00811311020492, 00811311020508, 00811311020522, 00811311020539 |
| Lot numbers | 17917092, 17923717, 17929776, 17931107, 301576 |
| Model numbers | SR0930CS, SR0940CS, SR1030CS, SR1040CS |
Product
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Reason for recall
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1146-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.