Device Recall Myocardial Heart Wires

  • Modèle / numéro de série
    Model Number TME60S, Lot #C1-07101 Model Number TME64S, Lot #C1-07056 Model Number TME64S, Lot #C1-07057 Model Number TME64S, Lot #C1-07058 Model Number TME64S, Lot #C1-07111 Model Number TME64S, Lot #C1-07112 Model Number TME64S, Lot #C1-07113 Model Number TME64S, Lot #C1-07114 Model Number TME64S, Lot #C1-07122 Model Number TME64S, Lot #C1-07123 Model Number TME64S, Lot #C1-07124 Model Number TME64S, Lot #C1-07125 Model Number TME64C, Lot #C1-07143 Model Number TME64S, Lot #C1-07151 Model Number TME64S-3, Lot #C1-07156 Model Number TME65S, Lot #C1-07174
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including OR, FL, Al, TX, NM, CA, AL, PA, KY, IN, OH, and IL and internationally to Canada, Russia, and New Zealand
  • Description du dispositif
    Myocardial Heart Wires || Intended for temporary atrial and ventricular pacing and sensing during or after cardiac surgery in conjunction with an external pulse generator.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Oscor, Inc., 3816 Desoto Boulevard, Palm Harbor FL 34683-1618
  • Société-mère du fabricant (2017)
  • Source
    USFDA