Events

Device Recall DLP Femoral Arterial Cannula; DLP Femoral Cannula and Insertion Kit (w. Femoral Arterial Cannula) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Perfusion Systems 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
    71517
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1914-2015
  • 사례 시작날짜
    2015-06-12
  • 사례 출판 날짜
    2015-06-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-03-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138058
  • 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, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
  • 원인
    Medtronic is recalling select lots of dlp femoral arterial cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
  • 조치
    Medtronic sent an Urgent Medical Device Recall letter, dated June 2015 to customers beginning June 12, 2015. The letter identified affected product, described the issue, requested that unused inventory be quarantined and returned to Medtronic. Customers should contact Customer Service at 800-854-3570 and reference RADAR #241958 to initiate a return and credit of product. Additionally a Customer Confirmation Certificate should be completed and faxed to 651-367-0612.

Device

Device Recall DLP Femoral Arterial Cannula; DLP Femoral Cannula and Insertion Kit (w. Femoral Ar...
  • 모델명 / 제조번호(시리얼번호)
    Model 57414 / Lot Numbers: 2014124994, 2015016150, 2015016729, 2015020381, 2015021484, and 201501C886.   Model 57417 / Lot Numbers: 2014125438, 2015016317, 2015016695, 2015020566, 2015021401, 2015030166, 2015030435, 2015030629, and 201503C101.    Model 57421 / Lot Numbers: 2015016410 and 2015017102.   Model 96017 / Lot Numbers: 2015021260 and 2015030499    Model 96021 / Lot Number: 2015021134.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution including the states of : AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, and WI., and to the countries of : Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Morocco, Netherlands, Poland, Qatar, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
  • 제품 설명
    Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized using Ethylene Oxide. || The cannula and dilator components are polyurethane and have tapered proximal tips to aid in diameter transition from the dilator. The dilator components utilize tip indicator bands for minimum tip alignment of the component parts. The cannula body is marked for depth insertion. The components are designed to fit over each other to progressively dilate the vessel during insertion. The dilator allows a 0.1-cm (0.038-in) guidewire to pass through it to aid in insertion. A soft, tapered transition fitting terminates in a 0.95-cm (3/8-in) connection site or barbed || connector.
  • Manufacturer
    Medtronic Perfusion Systems

Manufacturer

Medtronic Perfusion Systems
  • 제조사 주소
    Medtronic Perfusion Systems, 7611 Northland Dr N, Brooklyn Park MN 55428-1088
  • 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