Device Recall CSFUnitized Shunt

  • 모델명 / 제조번호(시리얼번호)
    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.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    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.
  • 제품 설명
    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

제조사

  • 제조사 주소
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-3083
  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    USFDA