Device Recall Boston Scientific, INGEVITY MRI Leads, Sterile EO, RxOnly.

  • Modèle / numéro de série
    Model 7740  S/N 633464, 610662. Model 7741  S/N 657588, 563539, 628198, 636545, 641593, 656713, 656904. Model 7742  S/N 572200, 584869, 631202. Model 7732  S/N 488740. Model 7736  S/N 631322, 632188.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide Distribution - US Distribution to the states of : IA and NY., and to the countries of : United Kingdom, Netherlands, Italy, Germany and Belgium.
  • Description du dispositif
    Boston Scientific, INGEVITY" MRI Leads, Sterile EO, RxOnly.
  • 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