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U.S. Department of Health and Human Services

Class 2 Device Recall VariLase WireFiber

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 Class 2 Recall
VariLase WireFiber
see related information
Date Posted March 03, 2011
Recall Status1 Terminated on May 03, 2012
Recall Number Z-1521-2011
Recall Event ID 57847
Premarket Notification
510(K) Number
K072332 
Product Classification Powered Laser Surgical Instrument - Product Code GEX
Product Vari Lase WireFiber Laser Fiber, RED 7137, Rx ONLY, Sterile EO, Vascular Solutions Inc., 6464 Sycamore Court, Minneapolis, MN 55369 The VARI-LASE WireFiber is indicated for the treatment of varicose veins and varicosities associated with superficial reflux in the Great Saphenous Vein and for treatment of incompetence and reflux of superficial veins in the lower extremity.
Code Information Lot #'s 550896 and 550898
Recalling Firm/
Manufacturer
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove, Minnesota 55369-6032
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Investigations of a recent Device Experience Report has made us aware of a potential problem with our Vari-Lase WireFiber, Model 7137, manufactured with the following lot numbers: 5500898 and 550896. Recently it was reported that the endovenous laser fiber cage and guidewire tip of the WireFiber became separated. It is possible that separation could occur during patient procedure and has the p
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Vascular Solutions sent an "Urgent Medical Device Recall" letter dated January 10, 2011. The letter described the issue and the product affected. Advised consignees to immediately check their inventory , place affected product in a secure location, and to complete and return the Customer Inventory Form. For questions regarding this recall call 763-656-4210.
Quantity in Commerce 41
Distribution Nationwide Distribution - USA including CT, MA, MN, NY, VA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEX and Original Applicant = VASCULAR SOLUTIONS, INC.
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