Silk Road Medical Inc: Medical Device Recall in 2021 - (Recall #: Z-1146-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Product Classification:

Class II

Date Initiated: January 13, 2021

Date Posted: March 3, 2021

Recall Number: Z-1146-2021

Event ID: 87196

Reason for Recall:

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

Status: Terminated

Product Quantity: Total = 455 systems

Code Information:

Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211130(10)17917092 Lot Number: 17917092 Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211231(10)17923717 Lot Number: 17923717 Catalog Number: SR1030CS UDI Code: (01)00811311020522(17)220131(10)17929776 Lot Number: 17929776 Catalog Number: SR1040CS UDI Code: (01)00811311020539(17)220131(10)17931107 Lot Number: 17931107 Catalog Number: SR0940CS UDI Code: (01)00811311020508(17)230131(10)301576 Lot Number: 301576

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated