—#72501

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.

FDA product code: MJN — Catheter, Intravascular Occluding, Temporary
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: Lots # 58320651, 58320652, 58323511, 58323512, 58323513, 58326739, 58326740, 58326741, 58329130, and 58329131

Why it was recalled

Potential for tubing fracture near the tip of the catheter.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Edwards Lifesciences, LLC
Address: 1 Edwards Way, Irvine, California 92614-5688

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-06-23
Posted by FDA: 2008-10-03
Terminated: 2012-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #72501. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.