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Terminated

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.

FDA Recall Z-2075-2009 · Posted 2009-09-10

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeLKK
Date Initiated2009-08-27
Date Terminated2011-12-12
Product Quantity20,000 of all products

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.

Firm 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".

Root Cause

Device Design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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