Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli

FDA device recall Z-0013-2009 · posted 2008-10-03 · Terminated

Recall details

Recalling firm

Edwards Lifesciences, LLC

Reason for recall

Potential for tubing fracture near the tip of the catheter.

Action taken

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

Root cause

Process control

Status

Terminated

Product code

MJN

Quantity affected

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

Date initiated

2008-06-23

Date posted

2008-10-03

Date terminated

2012-09-19

Location

Irvine, CA