Vitality

  • Model / Serial
    see letter
  • Product Description
    AIMD: Defibrillator, implantable, automatic, dual-chamber Pacemaker, cardiac, implantable Defibrillator, implantable, automatic
  • 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
    SATP

55 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
  • Model / Serial
    Model No: 07.02066.001 (All lots); 07.02053.001 (All lots distributed prior to April 26, 2017), and 730M0017 (Lot 309622)
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide, military/VA/govt and foreign consignee (No Canadian consignees)
  • Product Description
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
  • Manufacturer
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