Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

  • Model / Serial
    Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including AZ, CA, CO, CT, DC, FL, GA, IL, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, and WI.
  • Product Description
    TandemHeart Transseptal Cannulas-EF set (THTC-EF) - Dilator assembly || The TandemHeart Transseptal Cannula Set-EF is intended for transseptal catheterization of the left atrium via the femoral vein for the purpose of providing a means for temporary (six hours or less) left ventricular bypass when connected to the TandemHeart extracorporeal blood pump which returns blood to the patient via the femoral artery or other appropriate site.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Cardiac Assist, Inc, 240 Alpha Dr, Pittsburgh PA 15238-2906
  • Manufacturer Parent Company (2017)
  • Source
    USFDA