Events

Device Recall Boston Scientific Synchro 2 Guidewire 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Boston Scientific 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
    56388
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0872-2011
  • 사례 시작날짜
    2010-06-07
  • 사례 출판 날짜
    2011-01-07
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=96155
  • 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
    Wire, guide, catheter - Product Code DQX
  • 원인
    The guidewire has the potential to flake off polytetrafluroethylene (ptfe) particulate, which has the potential to embolize and result in infarction when introduced into a patient's circulatory system.
  • 조치
    Boston Scientific Corporation sent an Urgent Medical Device Recall letter dated June 7, 2010, by Federal Express to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use of and segregate the affected product. Complete and return the Reply Verification Tracking Form even if they did not have any affected product. Contact the Customer Service Call Center to obtain a Returned Goods Authorization (RGA) Number at (800) 811-3211, Option #1. E-mail or Fax the completed and signed Reply Verification Tracking Form to email Bob.Ware@bsci.com or the Field Action Fax (510) 624-2475. PackageShip and return the affected product along with the original Reply Verification Tracking Form by Federal Express to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: ____________ For questions regarding this recall call (510) 624-2563.

Device

Device Recall Boston Scientific Synchro 2 Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Material # M00326410: lot/use by dates: B17096 7/31/2011  B17097 7/31/2011  B17098 7/31/2011  B17099 7/31/2011  B17185 7/31/2011  B17186 7/31/2011  B17187 7/31/2011  B17188 7/31/2011  B17198 7/31/2011  B17199 7/31/2011  B17287 7/31/2011  B17288 7/31/2011  B17327 8/31/2011  B17328 8/31/2011  B17329 8/31/2011  B17330 8/31/2011  B17331 8/31/2011  B17390 8/31/2011  B17391 8/31/2011  B17392 8/31/2011  B17393 8/31/2011  B17394 8/31/2011  B17469 8/31/2011  B17470 8/31/2011  B17472 8/31/2011  B17473 8/31/2011  B17474 8/31/2011  B17504 8/31/2011  B17507 8/31/2011  B17508 8/31/2011  B17509 8/31/2011  B17510 8/31/2011  B17602 9/30/2011  B17664 9/30/2011  B17665 9/30/2011  B17714 9/30/2011  B17715 9/30/2011  B17716 9/30/2011  B17717 9/30/2011  B17718 9/30/2011  B17719 9/30/2011  B17825 10/31/2011  B17826 10/31/2011  B817851 9/30/2011  B17931 10/31/2011  B17932 10/31/2011  B17933 10/31/2011  B17934 10/31/2011  B17984 10/31/2011  B17985 10/31/2011  B17986 10/31/2011  B17987 10/31/2011  B18003 10/31/2011  B18004 10/31/2011  B18082 10/31/2011  B18198 11/30/2011  B18200 11/30/2011  B18201 11/30/2011  B18202 11/30/2011  B18259 11/30/2011 B18260 11/30/2011  B18261 11/30/2011  B18266 11/30/2011  B18267 11/30/2011  B18268 11/30/2011  B18315 11/30/2011  B18316 11/30/2011  B18317 11/30/2011  B18318 11/30/2011  B18319 11/30/2011  B18394 12/31/2011  B18444 12/31/2011  B18445 12/31/2011  B18446 12/31/2011  B18447 12/31/2011  B18448 12/31/2011  B18449 12/31/2011  B18479 12/31/2011  B18480 12/31/2011  B18481 12/31/2011  B18484 12/31/2011  B18535 12/31/2011  B18536 12/31/2011  B18537 12/31/2011  B18538 12/31/2011  B18701 12/31/2011  B18742 1/31/2012  B18743 1/31/2012  B18812 1/31/2012  B18813 1/31/2012  B18814 1/31/2012  B18815 1/31/2012  B18816 1/31/2012  B18841 1/31/2012  B18842 1/31/2012  B18934 1/31/2012  B18987 2/29/2012  B18988 2/29/2012  B19023 2/29/2012  B19024 2/29/2012  B19110 2/29/2012  B19120 2/29/2012  B19187 3/31/2012  B19346 3/31/2012  B19379 3/31/2012  819384 3/31/2012
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • 제품 설명
    Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • 제조사 주소
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • 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
    USFDA