ELUVIA™ Over the Wire Drug-Eluting Vascular Stent

  • Model / Serial
    Model Number: ELUVIA H74939295601570, H74939295601510, H74939295701570, H74939295701510 Innova (Class IIb, GMDN 47932: Multiple Peripheral Artery Stent , Commercial name: Innova ™ Over the Wire Self-Expanding Stent) H74939180051870, H74939180052070, H74939180061870, H74939180062070, H74939180071870, H74939180072070, H74939180081870, H74939180082070, H74939181051830, H74939181052030, H74939181061830, H74939181062030, H74939181071830, H74939181072030, H74939181081830, H74939181082030
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
  • 1 Event

Manufacturer

  • 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
    MHSIDCCCDMIS

2 devices with a similar name

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  • Model / Serial
  • Product Description
    Boston Scientific: ELUVIA™ Over the Wire Drug-Eluting Vascular Stent System
  • Manufacturer