Events

Recall of Device Recall Fogarty Fortis Arterial Embolectomy Catheter

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
    49003
  • Event Risk Class
    Class 2
  • Event Number
    Z-0013-2009
  • Event Initiated Date
    2008-06-23
  • Event Date Posted
    2008-10-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72501
  • 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
    Intravascular Occluding Catheter - Product Code MJN
  • Reason
    Potential for tubing fracture near the tip of the catheter.
  • Action
    The firm sent Urgent Field Safety Notices dated June 23, 2008 to customers. The letter gave details on affected products, a description of the problem, and advise on action to be taken. Edwards has decided to recall these lots of Fogarty Fortis catheters which were manufactured between 9 June 2007 and 20 June 2008. The expiration date for these lots is between 11 September 2009 and 26 September 2009. The attached sheet lists product by model and lot number which you have ordered during that time frame. Please stop using these lots of catheter products immediately. Edwards requests that you return all Fogarty Fortis catheters from these lots that are still in your inventory. Please call Edwards Customer Service to arrange for return of any unused product and obtain information about replacement product. After you have verified your inventory, please complete the attached Confirmation Form, even if you no longer have any affected units at your facility. This will allow us to verify the completion of this recall action. Please return the Confirmation Form by FAX to: +31.412.47.66.99 , Attention: Mark vanSchijndel Transmission of this Field Safety Notice: This notice needs to be passed on all those who need to be aware within your organization. Please transfer this notice to other organizations on which this action has an impact and where or to any organization where the potentially affected devices have been transferred. Please maintain awareness on this notice and resulting action for an appreciate period to ensure effectiveness of the corrective action. We sincerely regret the inconvenience caused by this action and greatly appreciate your immediate attention to this matter. If you have specific questions about this notification, please contact Customer Service

Device

Device Recall Fogarty Fortis Arterial Embolectomy Catheter
  • Model / Serial
    Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan.
  • Product Description
    Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter || Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
  • Manufacturer
    Edwards Lifesciences, LLC

Manufacturer

Edwards Lifesciences, LLC