Device Recall Vascular Solutions, Pronto V4, Extraction Catheter

  • Modèle / numéro de série
    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
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    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.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
  • Source
    USFDA