Class 1 Device Recall Medtronic Indura 1P Intrathecal Catheter

• Date Initiated by Firm: August 27, 2009
• Date Posted: September 10, 2009
• Recall Status: Terminated on December 12, 2011
• Recall Number: Z-2073-2009
• Recall Event ID: 53129
• PMA Number: P860004S081
• Product Classification: Intrathecal Catheter - Product Code LKK
• Product: 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.
• Code Information: Model 8709SC used with all IsoMed Pump Models including 8472. Not lot or serial number specific.
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 7000 Central Ave NE; Minneapolis MN 55432-3568
• For Additional Information Contact: 763-526-9684
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Device Design
• 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".
• Quantity in Commerce: 20,000 of all products
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LKK and Original Applicant = MEDTRONIC Inc.