Z-1146-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 3, 2021
- Initiation Date
- January 13, 2021
- Termination Date
- January 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Total = 455 systems
Product Description
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 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
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