Events

Recall of VNUS 7F ClosureFAST Catheter

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by VNUS Medical Technologies 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
    45510
  • Event Risk Class
    Class 2
  • Event Number
    Z-0543-2008
  • Event Initiated Date
    2007-08-08
  • Event Date Posted
    2008-01-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-05-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66271
  • 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
    Catheter - Product Code GEI
  • Reason
    Instructions for use change: instructions for use have been changed to include a modified placement recommendation.
  • Action
    The Recalling firm is updating the Instructions For Use, training materials, and procedural guides to incorporate the treatment recommendations. The recalling firm sent an Update to customers who received the product, Important Update Regarding the Use of the VNUS ClosureFAST Catheter, dated August 6, 2007 with supplemental device instructions. Future product distribution will include the updated labeling.

Device

VNUS 7F ClosureFAST Catheter
  • Model / Serial
    Lot #s: 269157,  269653,  269937,  273326,  277761,  286201,  286565,  287746,  288012,  288336,  288984,  289027,  289757,  291483,  295539,  295786,  296215,  296218,  296974,  298602,  299406,  301347,  301352,  302596,  303252,  304271,  305063,  305550,  306673,  306823,  307368,  308780,  308782,  312677,  312735,  313529,  314828,  314829,  314829,  315084,  315381,  317485,  317827,  317889,  317972,  317979,  318124,  318259,  318556, and  318610,
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide
  • Product Description
    VNUS 7F ClosureFAST Catheter, Order # ClF7-7-100 (100 cm working length), Manufactured by VNUS Medical Technologies, Inc., 5799 Fontanoso Way, San Jose, CA 95138
  • Manufacturer
    VNUS Medical Technologies Inc

Manufacturer

VNUS Medical Technologies Inc
  • Manufacturer Address
    VNUS Medical Technologies Inc, 5799 Fontanoso Way, San Jose CA 95138-1015
  • 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