Events

Device Recall Trevo Pro 4 Stent Retriever 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Concentric Medical Inc 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
    69799
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0528-2015
  • 사례 시작날짜
    2013-11-13
  • 사례 출판 날짜
    2014-12-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-12-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131562
  • 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, thrombus retriever - Product Code NRY
  • 원인
    Product shipped to us customers had non u.S. instruction for use with indication for use that were not aligned with u.S. indications.
  • 조치
    The firm, Concentric Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated November 18, 2013 to all affected customers by traceable mail. The letter described the product, problem, and actions to be taken. The customers were instructed to immediately locate the subject devices and quarantine them; distribute this notice to all affected departments in your facility; inform Concentric Medical (Stryker Neurovascular) if any of the subject devices have been distributed to other organizations; complete, sign and return the attached Customer Response Form via fax to: 1-866-876-4355 or email a copy to: NeuroComplaints@stryker.com, even if you do not have any subject devices to return, and keep a copy of the completed, signed Customer Response Form for your records. Should you have any queries concerning this matter, please do not hesitate to contact the QA Manager at 650-810-1716.

Device

Device Recall Trevo Pro 4 Stent Retriever
  • 모델명 / 제조번호(시리얼번호)
    Lot number/Expiration date: Lot Number 36774: March 2015 Lot Number 36432: December 2014 Lot Number 36757: March 2015 Lot Number 36761: March 2015
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Distribution to states of: CA, IN, PA, AL, and NJ.
  • 제품 설명
    Trevo Pro 4 Stent Retriever, || Model number 80021; || U.S. Indications for use: The Trevo Retriever is intended to restore blood || flow in the neurovasculature by removing thrombus in patients experiencing || ischemic stroke within 8 hours of symptom onset. Patients who are ineligible || for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA || therapy are candidates for treatment.
  • Manufacturer
    Concentric Medical Inc

Manufacturer

Concentric Medical Inc
  • 제조사 주소
    Concentric Medical Inc, 301 E Evelyn Ave, Mountain View CA 94041-1530
  • 제조사 모회사 (2017)
    Stryker
  • Source
    USFDA