Class 2 Device Recall Merci Retriever

• Date Initiated by Firm: June 25, 2014
• Date Posted: September 08, 2014
• Recall Status: Terminated on October 29, 2014
• Recall Number: Z-2598-2014
• Recall Event ID: 69119
• 510(K)Number: K082034
• Product Classification: Catheter, thrombus retriever - Product Code NRY
• Product: Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
• Code Information: Model Number 90109; Lot number 35695
• Recalling Firm/ Manufacturer: Concentric Medical Inc; 301 E Evelyn Ave; Mountain View CA 94041-1530
• For Additional Information Contact: Peter Henrich; 650-810-1707 Ext. 1716
• Manufacturer Reason for Recall: Merci Retrievers were shipped to US customers past their expiration date, even though they were labeled with the correct expiration date.
• FDA Determined Cause: Process control
• Action: Concentric sent an Urgent Medical Device Recall Notification dated June 25, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters were sent to Risk Manager- Director of Material and requested that the subject devices be quarantined and that Concentric be notified if the product has been distributed to other organizations. If so Concentric should be notified so that the additional customers can be notified. The response form should be completed and returned to Neuro Complaints @Stryuker.com. upon receipt of the response form, a representative will contact the firm to arrange for return and/or credit for the devices. Fax it to 1-866-876-4355. For further questions please call ( 650) 810-1707 Ext. 1716.
• Quantity in Commerce: 9 devices
• Distribution: US Distribution including the states of PA, CA, TX, NM, and OH.
• 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.

• 510(K) Database: 510(K)s with Product Code = NRY