Device Recall Endopledge Sinus Catheter Kit

  • Model / Serial
    Lot numbers: 751029B, 751036B, 751041B, 755814AB, 763115B, 763119B, 763123B, 763125B, 763127B, 763128B, 763129B, 774333B, 774334B, 774336B, 774337, 774337B, 784527B, 794302B, 794303, 794586, 798587, 818578, 818581, 821595, 831328, 833441, 841434, 848624, 848628, 848632, 856438, 856502, 856509, 856510, 856513.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. || 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

Manufacturer

  • Manufacturer Address
    Edwards Lifesciences, LLC, 12050 Lone Peak Pkwy, Draper UT 84020-9414
  • Manufacturer Parent Company (2017)
  • Source
    USFDA