—#84740

Product

Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. Medtronic, Inc., Minneapolis, MN 55432-5604 USA. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. 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 product code: LKK — Pump, Infusion, Implanted, Programmable
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P860004S081
Affected lot / code info: Model 8578 used with all IsoMed Pump Models including 8472. Not lot or serial number specific.

Why it was recalled

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.

Root cause (FDA determination)

Device Design

Action the firm took

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".

Recalling firm

Firm: Medtronic Neuromodulation
Address: 7000 Central Ave NE, Minneapolis, Minnesota 55432-3568

Distribution

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.

Timeline

Recall initiated: 2009-08-27
Posted by FDA: 2009-09-10
Terminated: 2011-12-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84740. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.