Events

Recall of Device Recall VariLase WireFiber

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Vascular Solutions, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    57847
  • Event Risk Class
    Class 2
  • Event Number
    Z-1521-2011
  • Event Initiated Date
    2011-01-10
  • Event Date Posted
    2011-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97562
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Powered laser surgical instrument - Product Code GEX
  • 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.
  • 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.

Device

Device Recall VariLase WireFiber
  • Model / Serial
    Lot #'s 550896 and 550898
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution - USA including CT, MA, MN, NY, VA
  • Product Description
    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.
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA