Events

Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy 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
    76352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1230-2017
  • 사례 시작날짜
    2016-12-07
  • 사례 출판 날짜
    2017-02-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-03-23
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152955
  • 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, peripheral, atherectomy - Product Code MCW
  • 원인
    Csi discovered that a 1.50mm solid crown oad was labeled as a 1.50mm crown oed.
  • 조치
    Cardiovascular Systems, Inc. sent an Urgent Medical Device Recall letter, dated 12/07/2016, to all affected customers. The letter identified affected product , stated the reason for recall, asked for product to be returned to CSI. Questions can be directed to Customer Service at 877-274-0901.

Device

Device Recall DIAMONDBACK 360 Peripheral Orbital Atherectomy System
  • 모델명 / 제조번호(시리얼번호)
    Lot: 171686, Expiration: 2018-09-30
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to LA, MS, SC, TX
  • 제품 설명
    DIAMONDBACK 360 Peripheral 1.50 Classic, Model DBP-150CLASS145 || Peripheral Orbital Atherectomy System (OAS) is a minimally invasive, catheter-based OAS designed for improving luminal diameter in patients with peripheral arterial disease (PAD). PAD is caused by the accumulation of plaque in the arteries of the leg or foot and reduces blood flow that may lead to pain, tissue loss, and eventual foot amputation, leg amputation or death. The system treats a broad range of plaque types in the lower limbs || The DIAMONDBACK 360 Peripheral Orbital Atherectomy System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The system is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. || The Stealth 360 Orbital PAD System is a percutaneous orbital atherectomy system indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy.
  • Manufacturer
    Cardiovascular Systems Inc

Manufacturer

Cardiovascular Systems Inc
  • 제조사 주소
    Cardiovascular Systems Inc, 1225 Old Highway 8 NW, Saint Paul MN 55112-6416
  • 제조사 모회사 (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA