Device Recall Protege GPS 8mm x 40mm Self Expanding Biliary Stent System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Ev3, Inc. 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    52642
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2022-2009
  • 사례 시작날짜
    2009-06-10
  • 사례 출판 날짜
    2009-09-08
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2011-12-11
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Diagnostic Biliary Catheter - Product Code FGE
  • 원인
    Ev3 inc. is conducting a voluntary recall of specific lots of the protege gps self-expanding stent system because labeling did not match the actual stent size contained in the package. the affected product was labeled as a 6mm x 80mm protege gps stent but actually contained an 8mm x 40mm stent. this situation can lead to vessel damage or inadequate coverage of the target lesion.
  • 조치
    Consignees were emailed a letter with a subject heading of "Medical Device Recall". The e-mail was dated June 10, 2009. The letter informed the consignee of the problem and product involved. They requested that any affected devices remaining in inventory be identified and returned and to fill out and return the "Device Recall Field Action Reconciliation Form".

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot #5283431
  • 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 Biliary Stent System, Rx Only, and SERB65-08-40-120. || 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

Manufacturer

  • 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