Device Recall Accolade MRI and Essentio MRI pacemakers

  • Modèle / numéro de série
    serial numbers 215173, 215186, 215507, 215855, 215957, 216051, 218956, 710312, and 710541.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Distributed to the states of TX, NH, MA, PA, and MN.
  • Description du dispositif
    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


  • Adresse du fabricant
    Boston Scientific Corporation, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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