Events

Device Recall Boston Scientific Synchro 14 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-0876-2011
  • 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=96161
  • 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 14 Guidewire
  • 모델명 / 제조번호(시리얼번호)
    Material # M00313010: lot/use by dates: B18331 11/30/2011  B18332 11/30/2011  B18333 11/30/2011  B18334 11/30/2011  B18335 11/30/2011  B18383 11/30/2011  B18384 11/30/2011  B18385 11/30/2011  B18386 11/30/2011  B18387 11/30/2011  B18388 11/30/2011  B18389 11/30/2011  B18544 12/31/2011  B18545 12/31/2011  B18546 12/31/2011  B18547 12/31/2011  B18548 12/31/2011  B18549 12/31/2011  B18650 12/31/2011  B18651 12/31/2011  B18652 12/31/2011  B18653 12/31/2011  B18654 12/31/2011  B18655 12/31/2011  B18656 12/31/2011  B18657 12/31/2011  B18843 1/31/2012  B18844 1/31/2012  B18845 1/31/2012  B18887 1/31/2012  B18888 1/31/2012  B18889 1/31/2012  B18890 1/31/2012  B18891 1/31/2012  B18897 1/31/2012  B18898 1/31/2012  B18899 1/31/2012  B18900 1/31/2012  B18901 1/31/2012  B18902 1/31/2012  B19094 2/29/2012  B19095 2/29/2012  B19106 2/29/2012  B19107 2/29/2012  B19108 2/29/2012  B19233 3/31/2012  B19235 3/31/2012  B19240 3/31/2012  B19298 3/31/2012  B19299 3/31/2012  B19389 3/31/2012  B19390 4/30/2012  B19454 4/30/2012  B19466 4/30/2012 .
  • 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 Synchro.14" Guide Wire, 35 cm, tip; || 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