Pacemakers and CRT-P

  • Modelo / Serial
  • Descripción del producto
    Product name Models VALITUDE™ CRT-P U125, U128 ACCOLADE™ Pacemakers L300, L301, L310, L311, L321, L331 ESSENTIO™ Pacemakers L100, L101, L110, L111, L121, L131 VISIONIST™ CRT-P U225, U226, U228 PROPONENT™ Pacemakers L200, L201, L209, L210, L211, L221, L231 ALTRUA™ 2 Pacemakers S701, S702, S722In addition to the FSN which details affected product, please refer to the Excel spreadsheet below which accompanies this MDA for additional unique device identification information.
  • Manufacturer
  • 1 Event

Fabricante

  • 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
    MHRA