Recall Z-1521-2011 ยท GEX Powered Laser Surgical Instrument
Vascular Solutions, Inc.
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.
| Date | Mar 3, 2011 (initiated Jan 10, 2011) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 | 41 |
| Distribution | Nationwide Distribution - USA including CT, MA, MN, NY, VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072332 | VARI-LASE WIRE FIBER Vascular Solutions, Inc., Jan 10, 2008 |