Devices

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.
  • 1 Event

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

One device with a similar name

Learn more about the data here

Device Recall CardioVations Endoclamp(TM) Aortic Catheter
  • Model / Serial
    Lot numbers: MS0408007, MS0508033, MS0508040, 561241, 562406, 567576, 569133, 569134, 569135, 575695, 579683, and 581317.
  • 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
    Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. 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.