Events

Recall of Device Recall Evident MWA Generator

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

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
    59754
  • Event Risk Class
    Class 2
  • Event Number
    Z-3092-2011
  • Event Initiated Date
    2009-02-06
  • Event Date Posted
    2011-08-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103590
  • 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
    Electrosurgical, cutting & coagulation & accessories - Product Code GEI
  • Reason
    Generator may deliver full power when a lower power is selected.
  • Action
    Covidien sales reps began notifying affected customers on February 6, 2009, followed by a letter. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to return the affected product to: Covidien Energy Based Devices 5920 Longbow Road Boulder, Colorado 80301 Customers were asked to label the exterior of the carton with their Return Authorization number. Covidien EbD would address the issue and return the unit to them. For any questions customers were asked to call Covidien EbD's Service Department toll-free at 1-800-255-8522, x 4923 or contact their local sales representative for additional information.

Device

Device Recall Evident MWA Generator
  • Model / Serial
    Serial Numbers:  XP7K0101R to XP7K0120R, XP7L0121R to XP7L0140R, XP8B0141R to XP8B0167R, XP8C0168R to XP8C0231R, XP8D0232R to XP8D0320R, XP8E0321R to XP8E0390R, XP8F0391R to XP8F0485R, XP8H0578R to XP8H0615R, XP8I0626R to XP8I0660R, XP8J0661R to XP8J0690R, XP8L0701R to XP8L0730R.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Belgium, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Slovakia, Spain, Switzerland, and the UK.
  • Product Description
    Evident MWA Generator, REF VTGEN, Output: 60 W / 50 Ohm, Valleylab, a division of Tyco Healthcare Group LP Boulder, CO 80301. || Intended for the coagulation of soft tissue. Not intended for use in cardiac procedures.
  • Manufacturer
    Covidien, PLC

Manufacturer

Covidien, PLC
  • Manufacturer Address
    Covidien, PLC, 5920 Longbow Dr, Boulder CO 80301-3202
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA