Device Recall TandemHeart Transseptal CannulasEF set (THTCEF) Dilator assembly

  • Modèle / numéro de série
    Part number 5140-6221 - Lot numbers 2010060684 & 2010071887
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Cardiac Assist, Inc, 240 Alpha Dr, Pittsburgh PA 15238-2906
  • Société-mère du fabricant (2017)
  • Source
    USFDA