Device Recall Boston Scientific TSX Transseptal Needle

  • Modèle / numéro de série
    Lot Q823423, Exp 7/31/2018
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to one customer in the US.
  • Description du dispositif
    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; || Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • Société-mère du fabricant (2017)
  • Source
    USFDA