Events

Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific 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
    67298
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0900-2014
  • 사례 시작날짜
    2014-01-06
  • 사례 출판 날짜
    2014-01-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=125181
  • 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
    Transducer, ultrasonic, diagnostic - Product Code ITX
  • 원인
    Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lumen and exit port at the (proximal) y-manifold of the imaging catheter.
  • 조치
    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated January 14, 2014 to all affected customers by overnight mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete an Account Reply verification Tracking Form in order to received a Return Goods Authorization number for product return. For questions contact your local Sales Representative.

Device

Device Recall Atlantis PV 15 MHz Peripheral Imaging Catheter
  • 모델명 / 제조번호(시리얼번호)
    Product number: H749364560, Catalog number: 36456; Lot numbers:  16159358, 16183964, 16230195, 16230673, 16247263, 16257809, 16268498, 16289177, 16311356, 16330543, 16342824, 16419885, 16420624, 16420903, 16447744, 16458536, 16486133, 16494530; Expiration Date: June 11th 2014 to October 29th 2014.
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution and Mexico
  • 제품 설명
    Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: || Sterile, R; Sterilized using irradiation. || Product Usage: || This catheter is a 15 MHz ultrasound imaging catheter intended to operate with an IVUS instrument for diagnostic imaging. It is used with an 8.5F-introducer sheath and a 0.035 guidewire.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 47215 Lakeview Blvd, Fremont CA 94538-6530
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA