Events

Device Recall Diamondback 360 Coronary Orbital Artherctomy System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Cardiovascular Systems, 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
    70727
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1290-2015
  • 사례 시작날짜
    2015-03-04
  • 사례 출판 날짜
    2015-03-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134565
  • 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
    Catheter, coronary, atherectomy - Product Code MCX
  • 원인
    The oad saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. if the material is large enough, it has the potential to cause a flow limiting embolism.
  • 조치
    Consignees were sent on 3/4/2015 a CSI "Urgent Medical Device Recall" letter dated March 04, 2015. The letter described the problem and the affected product. Consignees were advised to remove and return the affected product to CSI. The letter also requested consignees to complete and return the Customer Acknowledgement Form by Fax or with the RGA (Returned Goods Authorization). For further information they can contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton, MN 55112, 877-274-0901 -Tel, 612-677-3355- Fax.

Device

Device Recall Diamondback 360 Coronary Orbital Artherctomy System
  • 모델명 / 제조번호(시리얼번호)
    107046, 106992, 106993, 106990.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-including the states of AZ, FL, GA, LA, MA, MS, MO, NJ, NY, OH, and RI.
  • 제품 설명
    Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. || The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions.
  • Manufacturer
    Cardiovascular Systems, Inc.

Manufacturer

Cardiovascular Systems, Inc.
  • 제조사 주소
    Cardiovascular Systems, Inc., 651 Campus Dr, Saint Paul MN 55112-3495
  • 제조사 모회사 (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA