FDA Medical Device Recalls (openFDA)
Silk Road Medical Inc: ENROUTE Transcarotid Stent System REF SR-XXYY-CS
- Recall number
- Z-1146-2021
- Recalling firm
- Silk Road Medical Inc
- Product
- ENROUTE Transcarotid Stent System REF SR-XXYY-CS
- Status
- Terminated
- Initiated
- 2021-01-13
- Posted
- not on file
- Terminated
- 2023-01-31
- 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 Recalling Firm can arrange for removal from their facility. The affected units will be permanently removed from commercial distribution. There is no need for action related to devices already used during a procedure. 2. Immediately upon receipt of the email notification, reply to the email to recall@silkroadmed.com and record the number of units for each affected lot 3. If not impacted products remain in their facility or a Recalling Firm's field representative has already removed the affected products, customer are to indicated this accordingly on the email reply. For any questions, contact the Recalling Firm at 855-410-8227 ext. 2110 Monday through Friday 8:00 a.m. to 5:00 p.m. Pacific Time or email recall@silkroadmed.com
- 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
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P140026"]
- Product code
- NIM
- Firm FEI
- 3007215228
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28