Events

Recall of Device Recall CardioVations Endoclamp(TM) Aortic Catheter

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
    50502
  • Event Risk Class
    Class 2
  • Event Number
    Z-0645-2009
  • Event Initiated Date
    2008-11-26
  • Event Date Posted
    2009-01-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-08-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75537
  • 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 rupture: catheter balloon may rupture during cardiopulmonary bypass procedure. for further information, please telephone edwards lifesciences research medical, inc. at 801-565-6173.
  • Action
    All consignees were notified by letter on 11/26/2008 and requested to return any unused product to Edwards. The letter was entitled "PRODUCT RECALL." Questions could be referred to the Edwards representative or call 800-424-3278.

Device

Device Recall CardioVations Endoclamp(TM) Aortic Catheter
  • Model / Serial
    Lot numbers: MS0208019, MS0208020, MS0208027, MS0208035, MS0208036, MS0408002, MS0408008, MS1007022, MS1007026, MS1207032, MS1207033, MS1207042, MS1207043, and MS1207044.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Globally - USA including the states of AK, AL, CA, CO, CT, DC, DE, FL, GA, IA, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, and WV. VA facilities in VA and WI. No military distribution. Foreign distribution to Australia, Canada, Switzerland and UK.
  • Product Description
    CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated for use in patients undergoing cardiopulmonary bypass. It 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