News | November 10, 2009

FDA Recalls Edwards Lifesciences' CardioVations EndoClamp Aortic Catheter

November 10, 2009 – FDA and Edwards Lifesciences notified healthcare professionals this week about the class 1 FDA recall of CardioVations EndoClamp Aortic Catheter, due to the potential that the balloon catheters may spontaneously rupture during surgery.

The recall includes model numbers EC1001 and EC65. The device blocks off the aorta, monitors aortic pressure and delivers solution to stop the heart during cardiopulmonary bypass procedures. This product was manufactured from August 2008 through August 2009 and distributed from November 2008 through September 2009.

For more information: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm189650.htm

Related Content

Bilateral Artery Use Does Not Improve 10-Year CABG Outcomes
News | Cardiovascular Surgery | September 06, 2018
While it is firmly established that the use of one internal thoracic artery can improve life expectancy in coronary...
Mandatory Public Coronary Artery Bypass Grafting Reporting Associated With Better Patient Outcomes
News | Cardiovascular Surgery | April 30, 2018
Mandatory public reporting of coronary artery bypass grafting (CABG) results in Massachusetts was associated with...
Gecko Biomedical Receives CE Mark Approval for Setalum Sealant
News | Cardiovascular Surgery | September 19, 2017
Gecko Biomedical announced it has received CE Mark approval for its Setalum Sealant, allowing the company to market its...
ClearFlow Inc. Announces Positive U.S. Clinical Trial Results
News | Cardiovascular Surgery | September 08, 2017
September 8, 2017 — ClearFlow Inc.
Videos | Cardiovascular Surgery | July 19, 2017
This video educational session, provided in partnership with the American Society of Echocardiography (ASE), is title
Intensive Glycemic Control Program Produces Significant Per-Patient Cost Savings for CABG Surgery
News | Cardiovascular Surgery | May 25, 2017
A new study from Emory University observed a near-20 percent reduction in perioperative complications, a 1.2-day...
Risk of Heart Transplant Rejection Reduced by Desensitizing Patient Antibodies
News | Cardiovascular Surgery | May 23, 2017
The risk of heart transplant rejection can be reduced by desensitizing patient antibodies, according to research...
Scientists Show How Cells React to Injury From Open-Heart Surgery
News | Cardiovascular Surgery | May 04, 2017
Cedars-Sinai Heart Institute investigators have learned how cardiac muscle cells react to a certain type of injury that...
ERACS Session Highlights Need for Standardized Best Practices in Cardiac Surgery
News | Cardiovascular Surgery | May 02, 2017
The recently formed group Enhanced Recovery After Cardiac Surgery (ERACS) hosted an organizing session in Boston on...
Overlay Init