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U.S. Department of Health and Human Services

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Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit

Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers

[Posted 10/02/2008] Medtronic and FDA notified healthcare professionals of the Class I Recall of several Medtronic intrathecal catheters and intrathecal catheter revision kits used with the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps that store and deliver parenteral drugs to the intrathecal space. The products were recalled because of potential misconnections of the Medtronic Sutureless Connector Catheters from the catheter port on the pump. These misconnections have resulted in a blockage between the sutureless pump connector and the catheter port on the pump and disconnection from the pump connector. See the FDA Recall Notice for recommendations for healthcare professionals.

[October 01, 2008 - Recall Notice - FDA]