FDA Device recall Z-1146-2021
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
- FDA Device
- Class II
- terminated
- Published 2021-03-03
On 2021-03-03 the FDA classified a Class II recall of ENROUTE Transcarotid Stent System REF SR-XXYY-CS by Silk Road Medical, citing due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1146-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-13 |
| Published | 2021-03-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Silk Road Medical |
| Distribution | 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 |
Product
ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Reason
Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
Identifiers
| code_info | Catalog Number: SR0930CS UDI Code: (01)00811311020492(17)211130(10)17917092 Lot Number: 17917092 Catalog Number: S…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1146-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.