Device Recall Everflex SelfExpanding Peripheral Stent with Entrust Delivery System

  • 모델명 / 제조번호(시리얼번호)
    Model No. EVD35-07-060-120, UDI 00821684051436, Lot No. A476328.   Model No. EVD35-07-120-120, UDI 00821684051467, Lot No. A476301.
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution to AZ, CA, GA, IA, IL, KY, MA, NC, NE, SC, TN, VA
  • 제품 설명
    Everflex Self-Expanding Peripheral Stent with Entrust Delivery System || Intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 140 mm in length in the native Superficial Femoral Artery (SFA) and/or proximal popliteal arteries with reference vessel diameters ranging from 4.5 - 7.5 mm.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Medtronic 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