Device Recall Complete SE Biliary Stent System, SC680L (6 mm x 120 mm)

  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0000983806, use by date 03/17/2011.
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Product was distributed to 24 consignees in TX, MO, PA, MN, NY, IL, CA, IN, AZ, TN, OH, MI, and CT.
  • 제품 설명
    Complete SE Biliary Stent System, SC680L (6 mm x 120 mm), lot number 0000983806, UPC code 006133994186669, use by date 03/17/2011, manufactured by Medtronic CardioVascular, Santa Rosa, CA. || Indicated for use in the palliation of malignant neoplasms in the biliary tree.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic CardioVascular, 3576 Unocal Pl, Santa Rosa CA 95403
  • 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