Events

Device Recall HeartMate II Implant Kit with Pocket Controller; 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Thoratec Corporation 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
    67639
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1227-2014
  • 사례 시작날짜
    2014-03-04
  • 사례 출판 날짜
    2014-03-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125886
  • 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
    Discovery of serious injuries and deaths associated with the process of changing from a primary system controller to their back-up system controller in patients using the pocket system controller model.
  • 조치
    Thoratec sent an Urgent Medical Device Correction letter dated March 4, 2014 to all affected customers. The letter was sent via e-mail. All distributors outside of the USA and Canada to whom affected product has been distributed have been notified of this field correction notice and have been provided copies of the Customer Letter to forward to their customers. The letter identified the affected product , problem and actions to be taken. Customers were requested to complete and sign the attached Acknowledgement Form and return it to Thoratec via fax (925-847-8571) or e-mail a scanned copy to customer.service@thoratec.com. For questions call 1-800-528-2577.

Device

Device Recall HeartMate II Implant Kit with Pocket Controller;
  • 모델명 / 제조번호(시리얼번호)
    Catalog number 106015 (NAm) 106016 - EU all serial numbers
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: US (nationwide) including states of: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI; and countries of: Austria, Belgium, Czech Republic, France, Germany, Ireland, Israel, Italy, Lebanon, Lithuania, Poland, Saudi Arabia, Singapore, Slovenia, Sweden, Switzerland, The Netherlands, Turkey, and United Kingdom.
  • 제품 설명
    HeartMate II Implant Kit with Pocket Controller; || with sealed grafts (NAm) || with sealed grafts (EU) || Product Usage: HeartMate II is a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.
  • Manufacturer
    Thoratec Corporation

Manufacturer

Thoratec Corporation
  • 제조사 주소
    Thoratec Corporation, 6035 Stoneridge Dr, Pleasanton CA 94588-3270
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA