Z-1146-2021Class II

ENROUTE Transcarotid Stent System REF SR-XXYY-CS

Name: Z-1146-2021 ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Creator: Silk Road Medical Inc
Published: 2021-01-13
License: https://open.fda.gov/license/

Silk Road Medical / initiated 2021-01-13 / Terminated

FDA source

Silk Road Medical Inc began a recall of ENROUTE Transcarotid Stent System REF SR-XXYY-CS on 2021-01-13. FDA classified it as Class II and gives the reason as "Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1146-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-13
Posted: 2021-02-23
Terminated: 2023-01-31
Recalling firm: Silk Road Medical
Product: ENROUTE Transcarotid Stent System REF SR-XXYY-CS
Product code: NIM Stent, Carotid
Reason for recall: Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
FDA 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 [email protected] 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 [email protected]
Quantity in commerce: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1146-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1146-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-23

Product code NIM

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)