Events

HALO360 Ablation Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Barrx Medical, 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
    49515
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0192-2009
  • 사례 시작날짜
    2008-09-18
  • 사례 출판 날짜
    2008-10-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-04-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73709
  • 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 filter - Product Code GEI
  • 원인
    Some units may contain the wrong filter, which does not have the proper lock and may result in a leak.
  • 조치
    The recall was initiated on September 18, 2008. All users and international distributors were informed by letter. The replacement filters were sent on 9/19/2008. Contact Barrx Medical, Inc. at 1-408-745-8000 for assistance.

Device

HALO360 Ablation Catheter
  • 모델명 / 제조번호(시리얼번호)
    Filter Lot number 78156 was packaged with Catheter Lot numbers: F1012714 , F1012715 , F1012716 , F1012718 , F1012721 , F1012723 , and F1012724, and/or with Sizing Balloon Lot number: F1012719.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution, including USA, Austria, Australia, Belgium, Canada, France, Netherlands, Switzerland, Sweden, and UK .
  • 제품 설명
    Hydrophobic HALO360 Filter that is || packaged with HALO360+ Ablation Catheters Model numbers 32041-22, 32041-28, 32041-31 and 32041-34, and/or with HALO360 Sizing Balloon Model number 3441B.
  • Manufacturer
    Barrx Medical, Inc.

Manufacturer

Barrx Medical, Inc.
  • 제조사 주소
    Barrx Medical, Inc., 540 Oakmead Pkwy, Sunnyvale CA 94085-4022
  • 제조사 모회사 (2017)
    Medtronic plc
  • 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