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U.S. Department of Health and Human Services

Class 2 Device Recall Traxcess 7 Mini Guidewire

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  Class 2 Device Recall Traxcess 7 Mini Guidewire see related information
Date Initiated by Firm August 07, 2017
Create Date September 01, 2017
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = MICROVENTION, INC.
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