Events

Recall of Device Recall Argoguide Hydrophilic Wire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Argon Medical Devices, 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
    51284
  • Event Risk Class
    Class 2
  • Event Number
    Z-1294-2009
  • Event Initiated Date
    2009-02-26
  • Event Date Posted
    2009-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=80673
  • 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
    Wire, guide, catheter - Product Code DQX
  • Reason
    Hydrophilic guidewires have the potential to demonstrate degradation of the pebax cladding.
  • Action
    Argon Medical Devices Inc. issued an "Urgent Field Safety Notice" letter dated February 26, 2009 informing all consignees of the affected product. Consumers were asked to immediately quarantine and return any product remaining followed by completion and return of the provided response form via email or fax (1-903-677-9396). For further questions or additional information call Argon Medical Devices Inc. at 1-903-677-9319.

Device

Device Recall Argoguide Hydrophilic Wire
  • Model / Serial
    All lot codes.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US including Puerto Rico and states of AL, CA, CO, FL, GA, IL, KS, LA, MA, MI, MN, MO, MT, NC, NJ, NV, NY, PA, SC, TN, TX, UT, VA and WI and countries of Germany, Thailand, Turkey and the Netherlands.
  • Product Description
    Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .032/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical Devices, Inc. Athens, TX 75751.
  • Manufacturer
    Argon Medical Devices, Inc

Manufacturer

Argon Medical Devices, Inc