Events

Medtronic Launcher Coronary Guide Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Vascular 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
    69488
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0205-2015
  • 사례 시작날짜
    2014-10-13
  • 사례 출판 날짜
    2014-11-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-02-18
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130755
  • 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, percutaneous - Product Code DQY
  • 원인
    Two reports have been received on the 6f launcher guide catheter lot (model number la6jr40k; lot no 0007244836} for incorrect usable length of the guide catheter. it was reported that the catheters had a usable length of 90 cm instead of 55 cm, which was specified on the packaging label. usable length is defined as the total length of catheter shaft from the distal end of the strain relief to the.
  • 조치
    Beginning October 13, 2014, Medtronic field representatives will being hand delivery of the customer communication to affected customers, notifying them of the issue, and requesting return of unaffected product. Customers will be asked to sign a certificate confirming they have received the notification and have taken the requested action. 1. Identify and quarantine all listed, unused product in your inventory. 2. Return all listed product in your inventory to Medtronic. Contact Customer Service at 888-283-7868 to initiate a product return and credit. Your Medtronic sales representative can assist you in the return of this product as necessary. 3. Complete the attached Customer Confirmation Certificate and email it to RS.CFQFCA@Medtronic.com or fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality.

Device

Medtronic Launcher Coronary Guide Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: 0007244836 MODEL: LA6JR40K
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution including the states of NC, IA, IL and KS.
  • 제품 설명
    Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
  • Manufacturer
    Medtronic Vascular

Manufacturer

Medtronic Vascular
  • 제조사 주소
    Medtronic Vascular, 35-37A Cherry Hill Drive, Danvers MA 01923-2565
  • 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