Device Recall Polaris Dx Diagnostic Catheter

  • Model / Serial
    Batch numbers 9535942, 9596195, 9618290. Catalog Model number/Product UPN number M00496630
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Product was distributed to 3 consignees in Florida and Tennessee.
  • Product Description
    Polaris Dx Diagnostic Catheter, for cardiac electrophysiology studies, Model M0049663S0
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Boston Scientific Corp, 2710 Orchard Pkwy, San Jose CA 95134
  • Source
    USFDA