Recall Z-1146-2021 ยท NIM Stent, Carotid
Silk Road Medical Inc
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
| Date | Jan 13, 2021 |
| Status | Terminated |
| Reason | Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System. |
| Root cause | Under Investigation by firm |
| Action | On 01/13/2021, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Notification via email to customers informing them that product complaints have been received where the tip/nose cone detached from the stent delivery system during use and it is possible the resulting patient harm can range from minor intervention required to retrieve the detached tip/nose cone to embolization or stroke if the device failure goes undetected. Customers are instructed to: 1. Immediately removed the affected lots from hospital inventory and quarantine the products in a secure location until such time as the Recall |
| Quantity | Total = 455 systems |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.