Class 2 Device Recall Fogarty Fortis Arterial Embolectomy Catheter

• Date Initiated by Firm: June 23, 2008
• Date Posted: October 03, 2008
• Recall Status: Terminated on September 19, 2012
• Recall Number: Z-0013-2009
• Recall Event ID: 49003
• Product Classification: Intravascular Occluding Catheter - Product Code MJN
• Product: 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.
• Code Information: Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131
• Recalling Firm/ Manufacturer: Edwards Lifesciences, LLC; 1 Edwards Way; Irvine CA 92614-5688
• For Additional Information Contact: 949-250-2500
• Manufacturer Reason for Recall: Potential for tubing fracture near the tip of the catheter.
• FDA Determined Cause: Process control
• 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
• Quantity in Commerce: 2,975 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.