StarMedTec LightTrail Reusable Fibers

Manufacturer

  • Manufacturer Address
    Boston Scientific Corporation, 100 Boston Scientific Way, Marlborough MA 01752-1234
  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

3 devices with a similar name

Learn more about the data here

  • Model / Serial
    Material/Part Number: 6453  Batch Code: 2011-00238
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY and TX.
  • Product Description
    StarMedTec LightTrail¿ Reusable Fibers, 365 um; Material/Part Number: 6453
  • Manufacturer
  • Model / Serial
    Material/Part Number: 6455  Batch Code: 2012-00268, 2013-00443
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of NY and TX.
  • Product Description
    StarMedTec LightTrail¿ Reusable Fibers, 600 um; Material/Part Number: 6455
  • Manufacturer