Device Recall CSFUnitized Shunt

  • Modelo / Serial
    Lot Numbers:  Catalog No. 46022: D27162; D30984; D3461 0; D35834; D37761; D39054; D39539.  Catalog No. 46024: D13944; D14093; D14217; D14216; D33526; D39540.  Catalog No. 46026: D35572; D39583.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) and Internationally to US and worldwide: Austria, Belgium, Bosnia, Herzegovina, Canada, Croatia, Germany, Japan, Poland, Portugal, Taiwan, United Arab Emirates, United Kingdom.
  • Descripción del producto
    CSF-Unitized Shunt, Contoured Regular, Low Pressure, Catalog No. 46022; || CSF-Unitized Shunt, Contoured Regular, Medium Pressure, Catalog No. 46024; CSF-Unitized Shunt, Contoured Regular, High Pressure, || Catalog No. 46026. || CSF-Unitized Shunt Kits are designed as integrated CSF-Flow Control Shunts for use in shunting cerebrospinal fluid from the lateral ventricle of the brain into the peritoneal cavity.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “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