Device Recall 7F Prelude Short Sheath Introducer

  • Model / Serial
    Lot Numbers: H1041469, H1041473, H1036880, H1041464.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide and other foreign consignees. No Canadian or VA/govt/military consignees.
  • Product Description
    7F Prelude¿ Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. || Produc Usage: || The Merit Prelude¿ Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The device can also provide access to a native or synthetic graft used for hemodialysis. The side port of the sheath allows adequate flow to perform temporary hemodialysis. The device is not indicated for long term vascular or hemodialysis access.
  • Manufacturer
  • 1 Event


  • Manufacturer Address
    Merit Medical Systems, Inc., 1600 W Merit Pkwy, South Jordan UT 84095-2416
  • Manufacturer Parent Company (2017)
  • Source