Device Recall AngioJet SOLENT Omni Thrombectomy Set

  • Modelo / Serial
    162185 162318
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
  • Descripción del producto
    AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • 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