Events

Device Recall 10 Fr FlexCath Select Steerable Sheath 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Disease Management 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
    70644
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1276-2015
  • 사례 시작날짜
    2015-02-23
  • 사례 출판 날짜
    2015-03-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-10-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=134194
  • 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
    Introducer, catheter - Product Code DYB
  • 원인
    Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the steerable sheath, outside of the patients bodies.
  • 조치
    The firm, Medtronic, Inc., sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 2015 to its consignees/customers. Medtronic representatives, beginning Monday, Feb 23, 2015 hand delivered the letter to US consignees/customers.. The letter was addressed to Physician, Risk Manager and Health Care Professional. The letter described the product, problem and actions to be taken. The consignees/customers were instructed to immediately quarantine all unused product; return all affected product to Medtronic; contact Customer Service at 1-800-848-9300 to initiate product return and to complete and return the Customer Confirmation Certificate to via email to: RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 to the attention of Customer Focused Quality. In additions, consignees/customers should share this notification with others in your organization. Your Medtronic field representative may assist the customers with identifying suitable replacement product. If you have any questions, contact Customer Service at 1-800-848-9300.

Device

Device Recall 10 Fr FlexCath Select Steerable Sheath
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 54790, 54860, 54876, 54877, 54878 ,72417, 72419.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) in states of: NC and IA; and countries of: AUSTRIA, BELGIUM, DENMARK, FRANCE, GERMANY, NETHERLANDS, POLAND, SPAIN, and UNITED KINGDOM.
  • 제품 설명
    Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. || The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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