Devices

CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 100 cm

Model / Serial
Model EC1001 (codes are recorded in the following format: Lot #/Expiration date): 581130/Aug-09; 582944/ Aug-09; 591423/Aug-09; 591424/Nov-09; 598990/Sept-09; 598992/Nov-09; 604411/Oct-09; 605844/Dec-09; 606674/Dec-09; 606676/Jan-10; 607104/Feb-10; 608371/Feb10; 608375/Feb-10; 608377/Feb-10; 608379/Mar-10; 618753/Mar-10; 623151/Mar-09; 624601/Mar-10; 624602/Apr-10; 628961/Apr-10; 628962/Apr-10; 630344/May-10; 634975/Jun-10; 634976/Jun-10; 643171/May-10;; 644544//Jun-10; 644545/Jul-10; 644546/Jul-09; 651860/Jul-10; 651861/Aug-10; 651862/Aug-10; and 651865/Sep-10.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution -- US, Europe, Canada, Australia, and Thailand.
Product Description
EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile || R, Edwards Lifesciences LLC Irvine, CA***". 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.
Manufacturer
Edwards Lifesciences Research Medical, Inc.
1 Event
- Recall of CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 100 cm

Manufacturer

Edwards Lifesciences Research Medical, Inc.

Manufacturer Address
Edwards Lifesciences Research Medical, Inc., 6864 South 300 West, Midvale UT 84047
Manufacturer Parent Company (2017)
Edwards Lifesciences Corporation
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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