Events

Avis De Sécurité sur Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Microcatheter, UltraFlow HPC Flow Directed Microcatheter and Xcelerator Hydrophillic Guidewire

Selon Swedish Medical Products Agency, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Sweden qui a été fabriqué par Micro Therapeutics, Inc. DBA (Doing Business As) ev3 Neurovascular.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici

Device

Pipeline Embolization Device, Alligator Retrieval Device, Marathon Flow Directed Microcatheter, U...

Manufacturer

Micro Therapeutics, Inc. DBA (Doing Business As) ev3 Neurovascular
  • Société-mère du fabricant (2017)
    Medtronic plc
  • 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
    SMPA