Device Recall Vascular Solutions, Pronto V4, Extraction Catheter

  • 모델명 / 제조번호(시리얼번호)
    Model Lot # 4005 (5.5F) 551391 551513 551579 551861   4006(6F) 551034 551178 551514 551578   551581 551583   4007 (7F) 551106 551249 552116   4008 (8F) 551107551362 551577 552163
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, DC, FL, ID, IL, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK ,OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.
  • 제품 설명
    Vascular Solutions, Pronto¿ V4, Extraction Catheter, Sterilized using ethylene oxide, Rx Only. The following sizes/model numbers are affected: 5.5F( 4005), 6F(4006, 7F(4007, 8F(4008) are involved in the recall. || The Pronto catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary and peripheral vasculature.
  • Manufacturer
  • 1 Event

제조사

  • 제조사 주소
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • 제조사 모회사 (2017)
  • Source
    USFDA