Events

Recall of CardioVations (Heartport) EndoClamp Aortic Balloon Catheter 100 cm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Edwards Lifesciences Research Medical, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53576
  • Event Risk Class
    Class 1
  • Event Number
    Z-0084-2010
  • Event Date Posted
    2009-11-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85900
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Vascular Clamp - Product Code DXC
  • Reason
    Balloon catheters were spontaneously rupturing during use.
  • 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.

Device

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.

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