Device Recall Steerable Coronary Sinus Catheter

  • Modèle / numéro de série
    Lot numbers: 678238B, 751043B, 755821B, 763122B.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. || Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Société-mère du fabricant (2017)
  • Source
    USFDA