Events

Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Boston Scientific 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
  • 날짜
    2004-07-26
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-des-stents-coronaires-express-2-et-taxus-express-2-de-la-societe-boston-scientific
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • 데이터 추가 비고
  • 조치
    Following several instances of non-deflation of the balloon during stent placement, Boston Scientific is recalling all Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems prior to corrective actions initiated. by the company in April and May 2004. Initially, on July 20, 200., in agreement with Afssaps, the company BOSTON SCIENTIFIC sent a fax to the health establishments concerned asking them to quarantine the stent systems TAXUS ™ Express2 ™ Monorail® and Express2 ™ Monorail® Coronary Stent Systems awaiting a recall notification of these devices including a precise list of affected lots. On July 23, 2004, the Boston Scientific company sent to the health establishments concerned a letter (26/07/2004) (16 KB) accompanied by a list specific to each establishment specifying the numbers of the lots concerned by the recall. The other European Competent Authorities have been informed of this measure by the manufacturer. Any incident or risk of serious incident on these devices must be declared in the context of materiovigilance to the French Agency for Health Safety of Health Products - Department of Vigilance - Fax: 01 55 87 37 02. This information concerns the directors health facilities, local correspondents for materiovigilance and pharmacists in health facilities using these devices, for dissemination to the services concerned.

Device

Express2 ™ Monorail® TAXUS ™ Stent Systems and Express2 ™ Monorail® Coronary Stent Systems

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    LAANSM