Device Recall Coronary sinus catheter

  • Modèle / numéro de série
    Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. || The Steerable Coronary Sinus Catheter 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 Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
  • Manufacturer
  • 1 Event

Fabricant

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