Class 2 Device Recall Traxcess 7 Mini Guidewire

• Date Initiated by Firm: August 07, 2017
• Create Date: September 01, 2017
• Recall Status: Terminated on October 26, 2018
• Recall Number: Z-3103-2017
• Recall Event ID: 77880
• 510(K)Number: K161803
• Product Classification: Guide, wire, catheter, neurovasculature - Product Code MOF
• Product: MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
• Code Information: Lot numbers 17030521, 17032821, and 17041831
• FEI Number: 3003523199
• Recalling Firm/ Manufacturer: Microvention, Inc.; 1311 Valencia Ave; Tustin CA 92780-6447
• For Additional Information Contact: Irina.Kulinets, PhD; 714-247-8159
• Manufacturer Reason for Recall: There is a potential for the hydrophilic coating on the guidewire to delaminate from the guidewire.
• FDA Determined Cause: Under Investigation by firm
• Action: Letters dated 8/7/2017 were issued on 8/7/2017 via overnight mail to the direct account medical facilities.
• Quantity in Commerce: 34 units
• Distribution: Distribution was made to medical facilities located in AZ, CA, CO, MA, MI, MN, MO, NY, OH UT, VA, and WI. There was no foreign/military/government distribution.
• 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 = MOF