Device Recall Concentric 7F Balloon Guide Catheter

  • Model / Serial
    Lot numbers 33367 and 33407
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA including AL, FL, GA, IL, MN, NY, OH, OR, PA, TX, VA, WA, and WV and one consignee in Turkey and one in Switzerland
  • Product Description
    Concentric 7F Balloon Guide Catheter (percutaneous catheter per 21 CFR 870.1250), REF 90072, manufactured by Concentric Medical, Inc., Mountain View, CA || Product is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. Not intended for use to deliver embolic agents or to perform angioplasty.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • Manufacturer Parent Company (2017)
  • Source
    USFDA