Events

Recall of Device Recall Medtronic Intrathecal Catheter Pump Segment Revision Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53129
  • Event Risk Class
    Class 1
  • Event Number
    Z-2075-2009
  • Event Initiated Date
    2009-08-27
  • Event Date Posted
    2009-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84739
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Intrathecal Catheter Pump Segment Revision Kit - Product Code LKK
  • Reason
    Current labeling for medtronic sutureless connector (sc) catheters and revision kits (hereafter referred to as sc catheters) incorrectly states that sc catheters are compatible with medtronic isomed¿ constant-flow infusion pumps. sc catheters are compatible with medtronic synchromed¿ ii and synchromed el pumps. medtronic has determined that sc catheters are not compatible with isomed pumps.
  • Action
    A "Medical Device Correction Notification" letter was issued on August 14, 2009 to implanting and managing physicians. The letter described the nature of the issue, scope of affected product, potential severity of the issue and provided recommendations. Physicians were instructed that Sutureless Connector (SC) catheters must not be used with IsoMed pumps for future revisions and implants. A copy of the letter was also sent to the Risk Manager at each hospital associated with physicians using SC catheters. Healthcare professionals were asked to complete and return the enclosed reply card. Direct questions to your Medtronic field representative or contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. Patient Management information is also available at http://www.professional.medtronic.com under the Heading, "Advisories".

Device

Device Recall Medtronic Intrathecal Catheter Pump Segment Revision Kit
  • Model / Serial
    Model 8596SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
  • Product Classification
    General Hospital and Personal Use Devices
  • 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 Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. Contents: 66-cm-pump segment with attached sutureless pump connector, Spinal segment strain-relief sleeves, Pump Segment strain-relief sleeves, connector pin. || 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
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA