# FDA recall Z-1146-2021

> **Silk Road Medical Inc** · Class II · device recall initiated 2021-01-13.

## 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.

## 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

## Key facts

- **Recall number:** Z-1146-2021
- **Recalling firm:** Silk Road Medical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-13
- **Report date:** 2021-03-03
- **Termination date:** 2023-01-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sunnyvale, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1146-2021

## Citation

> AI Analytics. FDA recall Z-1146-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1146-2021. Source: US FDA. Licensed CC0.

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