Events

Device Recall AMPLATZER TorqVue Delivery System with Pusher Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 AGA Medical 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
    36440
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0257-2007
  • 사례 시작날짜
    2006-10-02
  • 사례 출판 날짜
    2006-12-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2008-10-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48679
  • 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
    Cardiac Septal Occluder Delivery System - Product Code GBK
  • 원인
    Aga medical has found that microscopic tears can occur in the delivery system sterile packaging under accelerated stress testing with routine shipping configurations. these microscopic tears are a potential breach of the sterile barrier. aga has no confirmed complaints or adverse events related to this failure mode.
  • 조치
    An Urgent Recall Notice, dated 09/29/06, was sent to customers via facsimile or email and via Federal Express. The letter describes the issue and what product is affected. Unexpired product that is returned to AGA will be replaced. A response form is asked to be returned to AGA.

Device

Device Recall AMPLATZER TorqVue Delivery System with Pusher Catheter
  • 모델명 / 제조번호(시리얼번호)
    Order no. 9-TVSP7F-180/80, Lot Numbers: M03K16-18, M03K24-10, M03K28-30, M03L06-36, M03L12-04, M03M02-10, M04B17-36, M04E18-12, M04E27-16, M04H31-16, M04L15-16, M05C09-09, M05C25-06, M05D20-17, M05E05-20, M05E23-39. Order no. 9-TVSP8F-180/80, Lot Numbers: M03J17-08, M03K16-19, M03K24-11, M03K28-31, M03L06-37, M03L12-05, M03M02-11, M03M30-10, M04B17-37, M04E27-17, M04L08-10, M05A13-05, M05C25-08, M05E05-07, M05F17-10. Order no. 9-TVSP9F-180/80, Lot Numbers: M03J17-09, M03K16-20, M03K24-12, M03K28-32, M03L06-38, M03L12-06, M04E27-18, M04H03-21, M04L15-18, M05D11-12, M05D20-19.
  • 유통
    Worldwide, including USA, Puerto Rico, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Cuba, Denmark, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Israel, Italy, Japan, Jordan, Korea, Kuwait, Malaysia, Moroc, Mexico, Norway, Pakistan, Peru, Phillipines, Poland, Portugal, Saudi Arabia, Singapore, Slovak Republic, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, The Netherlands, Tunisia, Turkey, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • 제품 설명
    AMPLATZER TorqVue (cardiac septal occluder) Delivery System with Pusher Catheter Order no. 9-TVSP7F-180/80, 9-TVSP8F-180/80, 9-TVSP9F-180/80. [Breakdown of order no. ''9-TVSP-7F-180/80'' is as follows: 9-TVSP, French size (7F) - degree angle curve (180) / usable length in cm (80).] Sterile EO. Single Use Only. CAUTION: Investigational device limited by U.S. Law to Investigational Use. Manufactured in U.S.A. AGA Medical Corporation, 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. The AMPLATZER TorqVue Delivery System with Pusher Catheter consists of a radiopaque delivery sheath, translucent loading device, dilator, plastic vise, delivery cable, and pusher catheter. The delivery system also includes a high pressure Hemostasis valve with a swivel luer connector. The loading device, also with a full thread swivel luer connector, allows a positive fit and seal between sheath and loader. The translucent loader allows for visualization of the device and potentially the presence of air during transfer of device to the sheath.
  • Manufacturer
    AGA Medical Corporation

Manufacturer

AGA Medical Corporation
  • 제조사 주소
    AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
  • Source
    USFDA