Rappel de Pipeline Embolization (Pipeline classic), Alligator Retrieval , Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire

Selon National Organization for Medicines, ce/cet/cette rappel concerne un dispositif en/au/aux/à Greece qui a été fabriqué par Micro Therapeutics, Inc., USA.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici

Device

  • Modèle / numéro de série
  • Classification du dispositif
  • Description du dispositif
    Recovery of the Pipeline Embolization Device (Pipeline classic), Alligator Retrieval Device, Marathon Flow Directed Microcatheter (with Sword), UltraFlow HPC Flow Directed Microcatheter (with Stylix) and Xcelerator Hydrophilic Guidewire
  • Manufacturer

Manufacturer

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    NOM