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.
FDA Recall Z-1521-2011 · Posted 2011-03-03
Advertisement
Recalling FirmVascular Solutions, Inc.
Recall StatusTerminated
Product CodeGEX
Date Initiated2011-01-10
Date Terminated2012-05-03
Product Quantity41
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
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Nationwide Distribution - USA including CT, MA, MN, NY, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement