Device Recall Medtronic IsoMed

  • Model / Serial
    all serial numbers
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA including states of Washington D.C., Puerto Rico, and countries of Aruba, Australia, Austria, Belarus, Belgium, Brazil, Canada, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Faroe Islands, Finland, France, French Polynesia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Mexico, Netherlands, Netherlands Antilles, New Caledonia, Norway, Pakistan, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia and Montenegro, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City State.
  • Product Description
    Medtronic IsoMed Implantable Constant-Flow Infusion Pump, model 8472-60. The contents of the inner package have been sterilized by ethylene oxide gas. Reservoir size: 60 mL. Medtronic, Inc., 710 Medtronic Parkway NE, Minneapolis, MN 55432-5604, USA. The implantable Medtronic IsoMed Constant-Flow Infusion Pump is part of the IsoMed Constant-Flow Infusion System designed to contain and administer parenteral drugs to a specific site. The components of the IsoMed Constant-Flow Infusion System include the pump, Medtronic catheter, catheter accessories, Medtronic Refill kit, and Medtronic catheter access port kit. IsoMed pumps are implantable devices that store and dispense drugs according to a constant flow rate set during the manufacturing process.
  • Manufacturer
  • 3 Events

Manufacturer

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