Events

Recall of Device Recall Edwards Lifesciences Suction Wand

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

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
    65492
  • Event Risk Class
    Class 2
  • Event Number
    Z-1749-2013
  • Event Initiated Date
    2013-06-19
  • Event Date Posted
    2013-07-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=119271
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • Reason
    Edwards is recalling certain lots of rigid suction wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.
  • Action
    Edwards sent an Urgent Field Safety Notice Product Recall letter, dated June 19, 2013, via FedEx to all affected customers. Two additional attempts will be made to notify customers to return products. The letter idenditifed the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for any affected device in their inventory, quarantine all affected product from their inventory and return all devices to Edwards. Customers were instructed to acknowledge that they have reviewed the Recall Notice and confirm that they have taken appropriate action by completing, sign and dating the enclosed Recall Response Form and returning the form to Edwards by fax to Edwards Customer Service at 800-422-9329. Customers should contact Customer Service at 800-424-3278 to obtain a Returned Goods Authorization number to return their current product to and receive replacement product. Customers with questions were instructed to call Edwards Customer Service at 800-424-3278.

Device

Device Recall Edwards Lifesciences Suction Wand
  • Model / Serial
    Models S099 and S099B
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Canada.
  • Product Description
    Edwards Lifesciences Suction Wand, models S099 and S0998B || Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC
  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
    Edwards Lifesciences Corporation
  • Source
    USFDA