Events

Recall of Device Recall HydroFinity Guidewire

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nitinol Devices and Components, 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
    68419
  • Event Risk Class
    Class 1
  • Event Number
    Z-1816-2014
  • Event Initiated Date
    2014-05-28
  • Event Date Posted
    2014-06-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-01-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127556
  • 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
    Reports of outer polymer jacket to the core wire being damaged during use on the hydrofinity guidewire.
  • Action
    Covidien sent an Urgent Product Recall letter dated May 30, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any unused devices to Covidien, their account would be credited. Customers were also instructed to:: 1) Stop using product listed in this letter immediately 2) Segregate this product from other inventory 3) Fill out the reply (verification) form at the end of this letter ¿ If you do not have any product identified in this letter, please fax or email the completed form to Covidien at (877) 523-9109 or covidien8770@stericycle.com. ¿ If you do have product, your sales representative will assist you in completing the verification form and arranging for return of the product. ¿ Please fax the completed form to Covidien (877) 523-9109 or email to covidien8770@stericycle.com. 4) Your sales representative will be available to answer any questions regarding this recall and assist you in completing the verification form, returning product and addressing any account credits. This action is being conducted with the knowledge of the United States FDA and other regulatory authorities. ¿ Customers with questions were instructed to call (202) 310-5120. For questions regarding this recall call 202-310-5120. _

Device

Device Recall HydroFinity Guidewire
  • Model / Serial
    Model HPRS35180- all lots.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Italy, France, Norway, Sweden, Germany, Belgium, United Kingdom and Canada.
  • Product Description
    HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile. || 0.035 OD, Standard Shaft, Straight Tip, 180 CM Length; || Manufactured for Covidien, Plymouth, MN; || Manufactured by: NDC Inc., Fremont, CA. || Manufactured in Costa Rica || The HydroFinity Hydrophilic guidewire facilitates the introduction and placement of catheters and interventional devices to the desired anatomical location during diagnostic or interventional procedures.
  • Manufacturer
    Nitinol Devices and Components, Inc.

Manufacturer

Nitinol Devices and Components, Inc.
  • Manufacturer Address
    Nitinol Devices and Components, Inc., 47533 Westinghouse Dr, Fremont CA 94539-7463
  • Manufacturer Parent Company (2017)
    Nitinol Devices and Components, Inc.
  • Source
    USFDA