Device Recall Boston Scientific TSX Transseptal Needle

  • 모델명 / 제조번호(시리얼번호)
    Lot Q823423, Exp 7/31/2018
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to one customer in the US.
  • 제품 설명
    Boston Scientific TSX Transseptal Needle, Model Number M004TSX60o; || Used to create the primary puncture in the interatrial septum when passing an intruder and/or catheter through the septum from the right side of the heart to the left side.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Merit Medical Systems, Inc., 1600 West Merit Parkway, South Jordan UT 84095
  • 제조사 모회사 (2017)
  • Source
    USFDA