Class 2 Device Recall Trevo XP ProVue System

• Date Initiated by Firm: November 28, 2017
• Create Date: January 14, 2018
• Recall Status: Terminated on April 28, 2020
• Recall Number: Z-0347-2018
• Recall Event ID: 78716
• 510(K)Number: K113260 K132641
• Product Classification: Catheter, thrombus retriever - Product Code NRY
• Product: Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
• Code Information: UPN/Model No. 80052; Lot 63034
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• Manufacturer Reason for Recall: Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack.
• FDA Determined Cause: Packaging process control
• Action: The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested.
• Distribution: OUS only - NL, FR, IT, DE, BE
• 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