Device Recall Medtronic SynchroMed EL Programmable Infusion Pump

  • Model / Serial
    All SynchroMed EL and SynchroMed II pumps.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution --- USA including Washington D.C., and Puerto Rico, and countries of Algeria, Aruba, Austria, Belarus, Belgium, Croatia, Cyprus Czech Republic, Denmark, Egypt, Finland, France, French Polynesia, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy , Jordan Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Slovakia, Slovenia, Sough Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State, New Caledonia, Brazil, Dominican Republic, Mexico, Hong Kong, Singapore, Canada, Australia and Japan.
  • Product Description
    Medtronic SynchroMed EL Programmable Pump, Model 8626-10. 10 mL Reservoir. The contents [STERILE] of the inner package have been sterilized by ethylene oxide gas. The implantable Medtronic SynchroMed EL programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. || The SynchroMed EL lnfusion System is indicated for use when patient therapy requires the chronic infusion of drugs or fluids. The EL Infusion System with a 10 reservoir volume is indicated for use in the smaller patient who has insufficient body mass to support the larger SynchroMed EL pump or in patients who choose a smaller, lower profile pump when presented with the choice, when patient therapy requires the chronic infusion of drugs or fluids.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA