FDA recall Z-1146-2021

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

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

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