Device Recall Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System

  • 모델명 / 제조번호(시리얼번호)
    Lot # 6691788
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    International Distribution Only -- Brazil, Uruguay, & Malaysia.
  • 제품 설명
    ev3 The Endovascular Company, Protege GPS 8mm x 40mm Self Expanding Peripheral Stent System , Rx Only, and SERP65-08-40-120. || In the US, the intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the US, the intended for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, subclavian or renal arteries.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Ev3, Inc., 4600 Nathan Ln N, Plymouth MN 55442-2890
  • 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