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U.S. Department of Health and Human Services

Class 2 Device Recall Trevo XP ProVue System

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  Class 2 Device Recall Trevo XP ProVue System see related information
Date Initiated by Firm November 28, 2017
Create Date January 14, 2018
Recall Status1 Terminated 3 on April 28, 2020
Recall Number Z-0347-2018
Recall Event ID 78716
510(K)Number K132641  K113260  
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 2		 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 and Original Applicant = CONCENTRIC MEDICAL, INC.
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