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U.S. Department of Health and Human Services

Class 2 Device Recall ENROUTE Transcarotid Stent System

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  Class 2 Device Recall ENROUTE Transcarotid Stent System see related information
Date Initiated by Firm January 13, 2021
Create Date February 23, 2021
Recall Status1 Terminated 3 on January 31, 2023
Recall Number Z-1146-2021
Recall Event ID 87196
PMA Number P140026 
Product Classification Stent, carotid - Product Code NIM
Product ENROUTE Transcarotid Stent System REF SR-XXYY-CS
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
Recalling Firm/
Manufacturer		 Silk Road Medical Inc
1213 Innsbruck Dr
Sunnyvale CA 94089-1317
For Additional Information Contact Shari Rideout
650-793-3837
Manufacturer Reason
for Recall		 Due to complaints received that the tip/nose cone may detach from the Transcarotid Stent System.
FDA Determined
Cause 2		 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 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIM and Original Applicant = SILK ROAD MEDICAL, INC
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