Boston Scientific brand Matrix 3D Omega Standard Coils

  • Modèle / numéro de série
    Material Product Description Catalog # Batch Numbers Expiry Date   M0034751030 Matrix2¿ 3D-Omega Standard 475103 13097570 Oct2012   Coils 1 Omm x 30cm  M0034753060 Matrix2¿ 3D-Omega Standard 475306 13204826 Dec2012   Coils 3mm x 6cm  M0034754060 Matrix2¿ 3D-Omega Standard 475406 13199749 Dec2012   Coils 4mm x 6cm  M0034755080 Matrix2¿ 3D-Omega Standard 475508 13204829 Dec2012   Coils 5mm x 8cm  M0034755100 Matrix2¿ 3D-Omega Standard 475510 13097571 Oct2012   Coils 5mm x 10cm
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide distribution. USA, Argentina, Austria, Australia, Belgium, Bahrain, Brazil, Canada, Switzerland, Chile, China, Colombia, Serbia, Czech Republic, Germany, Denmark, Spain, Finland, France, Great Britain, Greece, Hong Kong, Hungary, Ireland, India, Israel, Italy, Jordan, Japan, South Korea, Lithuania, Latvia, Macau, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Taiwan, Turkey, Ukraine, Vietnam, and Yemen.
  • Description du dispositif
    Boston Scientific brand Matrix 3D Omega Standard Coils. Intended for embolization of certain intracranial aneurysms and for arterial and venous embolizations in the peripheral vasculature.
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Boston Scientific Corporation, Neurovascular, 47900 Bayside Parkway, Fremont, CA 94538, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 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