Cardioverter Defibrillator

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.”
  • Manufacturers representative
    Medilife s.a.l
  • Source
    RLMPH

78 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Description
    TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D). Priority 2 – Warning
  • Manufacturer
  • Model / Serial
  • Product Classification
  • Product Description
    Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™. Priority 1 – For Immediate Action
  • Manufacturer
  • Model / Serial
  • Manufacturer
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