Date Initiated by Firm |
September 24, 2009 |
Date Posted |
November 06, 2009 |
Recall Status1 |
Terminated 3 on April 25, 2012 |
Recall Number |
Z-0085-2010 |
Recall Event ID |
53576 |
510(K)Number |
K964161 K962510 K955132 K974175
|
Product Classification |
Vascular Clamp - Product Code DXC
|
Product |
EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta.
Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure. |
Code Information |
Model EC65 (codes are recorded in the following format: Lot #/Expiration date): 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10. |
Recalling Firm/ Manufacturer |
Edwards Lifesciences Research Medical, Inc. 6864 South 300 West Midvale UT 84047
|
For Additional Information Contact |
Customer Service 800-424-3278
|
Manufacturer Reason for Recall |
Spontaneous balloon rupture during use of the product.
|
FDA Determined Cause 2 |
Process control |
Action |
Customers were notified by an Urgent - Product Recall letter, dated 9/29/09, and instructed to check their inventory, identify any unused product and return it to the company. Customers are to contact Customer Service Organization at 1-800-424-3278 to obtain a Returned Goods Authorization number, information concerning replacement product, and if they have any questions. |
Quantity in Commerce |
2,737 total |
Distribution |
Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand. |
Total Product Life Cycle |
TPLC Device Report
|
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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.
|
510(K) Database |
510(K)s with Product Code = DXC and Original Applicant = HEARTPORT, INC.
|