Device Recall Medtronic INDURA 1P Intrathecal Catheter

  • Model / Serial
    All SC Catheters
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Product Description
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6 cm catheter and connector pin, Transparent Strain-relief sleeves (2), Anchors (4).
  • Manufacturer
  • 1 Event

Manufacturer

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

2 devices with a similar name

Learn more about the data here

  • Model / Serial
    Product having a Use By Date prior to 25 Aug 2014
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
  • Product Description
    Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm catheter and Connector pin, Transparent Strain-relief sleeves, and anchors. Contents of inner package are STERILE. || The implantable Medtronic INDURA 1P Model 8709SC Intrathecal Catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8709SC catheter. The catheter connects to the pump at the catheter port.
  • Manufacturer
  • Model / Serial
    Model 8709SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- US (including Washington D.C. and Puerto Rico), Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Poland, Portugal, Reunion, Romania, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.
  • Product Description
    Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The implanted infusion system components consist of a Medtronic pump and a model 8709SC Catheter. The catheter connects to the pump at the catheter port. Contents: 81.4-cm Catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6-cm catheter and connector pin, Transparent strain-relief sleeves, Anchors. || This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space.
  • Manufacturer