medical Class II Updated 2021-03-03

Silk Road Medical Inc recalls ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Recalled Product

ENROUTE Transcarotid Stent System REF SR-XXYY-CS


Hazard / Issue

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

Issued by

FDA

Affected States: 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
Lot/Code Info: 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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →