Device Recall Ventricular Assist Device 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 HeartWare 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
    65328
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1813-2013
  • 사례 시작날짜
    2013-05-16
  • 사례 출판 날짜
    2013-07-29
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Ventricular (assisst) bypass - Product Code DSQ
  • 원인
    Potential to electrostatic discharged (esd).
  • 조치
    HeartWare sent an Urgent Medical Device Correction Safety Notification letter on May 16, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to educate their patients about the HeartWare Controller and instructions for equipment handling stated in the IFU and recognized practices to avoid electrostatic discharge. The direct accounts were also told to scan and return the signed Acknowledgment Form via fax to 305-364-2665 or e-mail to quality@heartwareinc.com. Customers with questions were instructed to contact their HeartWare Representative or HeartWare Customers Service. For questions regarding this recall call 305-364-1575.

Device

  • 모델명 / 제조번호(시리얼번호)
    US product: Model 1400, 1401US, 1403US, 1404 International: Model 1400, 1401XX, 1407XX, 1408 ALL HEARTWARE CONTROLLER SERIAL NUMBERS
  • 의료기기 분류등급
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - USA including AL, AZ, CA, DC, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and WI. Internationally to: Australia, Austria, Belguim, Brazil, Canada, Chile, Croatia, Czech Republic, France, Germany, Greece, India, Israel, Italy, Japan, Lebanon, Lithuania, Luxemburg, Malaysia, Netherlands, New Zeland,Norway, Poland Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
  • 제품 설명
    Heartware HVAD Pump Implant Kit (Heartware Ventricular Assist Device)
  • Manufacturer

Manufacturer

  • 제조사 주소
    HeartWare Inc, 14400 Nw 60th Ave, Miami Lakes FL 33014-2807
  • 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