Events

Recall of Varilase

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
    27557
  • Event Risk Class
    Class 2
  • Event Number
    Z-0101-04
  • Event Initiated Date
    2003-10-09
  • Event Date Posted
    2003-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-11-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30065
  • 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
    An internal gasket of the fiber lock component of the vari-lase kit contains natural rubber latex, but the product labeling does not recognize the presence of latex and include the required cautionary statement.
  • Action
    Letters dated October 9, 2003 were sent to the consignees. The letters instruct the consignees to place the enclosed warning stickers, about latex in the product, on the boxes and pouches of any remaining product in inventory at the consignees. After completing the relabeling, consignees are to fill out the attached form and fax it to the firm to document the field correction.

Device

Varilase
  • Model / Serial
    Lot numbers S000102, 300537, and 300536.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was distributed nationwide in the United States and to Romania.
  • Product Description
    Vari-Lase Endovenous Laser Procedural Kit, Model 7000
  • Manufacturer
    Vascular Solutions, Inc

Manufacturer

Vascular Solutions, Inc
  • Manufacturer Address
    Vascular Solutions, Inc, 2495 Xenium Ln N, Minneapolis MN 55441-3625
  • Source
    USFDA