Device Recall ProntoShort Extraction Catheter

  • Model / Serial
    Lot Numbers: 544202, 545693 and 546614.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States (CA, CO, FL, GA, IA, IL, IN, KS, LA, MI, MO, NC, NE, NH, NV, NY, OH, OR, PA, SC, TX, VA, VT, WA and WI), Canada, France, Ireland, Israel, Italy, Netherlands, Spain, Sweden, Taiwan and Turkey.
  • Product Description
    Vascular Solutions Pronto-Short Extraction Catheter. Model 5030. The PRONTO-Short Extraction catheter is a dual lumen, over-the-wire (OTW) catheter with related accessories. The catheter is designed to be delivered through a 6F or larger introducer sheath over the included 0.018" (0.45mm) guidewire. Sterilized with ethylene oxide. Manufactured by: Vascular Solutions, Inc., 6464 Sycamore Court, Minneapolis, MN 55369 USA.
  • Manufacturer
  • 1 Event

Manufacturer

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