Device Recall Marquet Heartstring II Proximal Seal System

  • Model / Serial
    Lot numbers 12895788, 12946718, 25002866, 25004647, 13029141, 25005045, 25005622
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA and countries including: Japan, Mexico, Germany, Switzerland, Israel
  • Product Description
    Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ || Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemostasis and to facilitate the completion of a proximal anastomosis without application of an aortic clamp.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Maquet Cardiovascular, LLC, 45 Barbour Pond Dr, Wayne NJ 07470-2094
  • Manufacturer Parent Company (2017)
  • Source
    USFDA