Device Recall Accolade MRI and Essentio MRI pacemakers

  • Modelo / Serial
    serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Distributed to the states of TX, NH, MA, PA, and MN.
  • Descripción del producto
    Pacemakers: Accolade MRI DR Model L311; Accolade MRI DR EL Model L331; and Essentio MRI DR Model L111. || These pulse generators provide bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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