Events

Recall of Device Recall AquaLiner Hydrophilic Guidewire

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

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
    63302
  • Event Risk Class
    Class 2
  • Event Number
    Z-0137-2013
  • Event Initiated Date
    2012-07-27
  • Event Date Posted
    2012-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-05-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113448
  • 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
    Nipro medical corporation, miami, fl recalled their aqualiner hydrophilic guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional.
  • Action
    Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.

Device

Device Recall AquaLiner Hydrophilic Guidewire
  • Model / Serial
    Item Code: AL+60000003 Lot #: 11F20, 11I27, 12B10
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil.
  • Product Description
    AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. || AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.
  • Manufacturer
    Nipro Medical Corporation

Manufacturer

Nipro Medical Corporation
  • Manufacturer Address
    Nipro Medical Corporation, 3150 Nw 107th Ave, Miami FL 33172
  • Manufacturer Parent Company (2017)
    Nipro Corporation
  • Source
    USFDA