Device Recall Percutaneous Catheter

  • Model / Serial
    559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931, 554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827, 560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029,  554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079,  560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253, 554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115, 561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707, 560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459, 554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223, 560995, 560996.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM.
  • Product Description
    Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341. || Product Usage: || The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Manufacturer Parent Company (2017)
  • Source
    USFDA