Sunnyvale, CA, United States
Silk Road Medical Inc recalls
1 recall recorded since 2018, most recently on 13 January 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 January 2021
- Terminated
- 31 January 2023
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1146-2021
- ENROUTE Transcarotid Stent System REF SR-XXYY-CS
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.