FDA Issues Recall of Medtronic Infusion Pump

Recall Prompted by Potential for Life-Threatening Blockages

Medtronic and the Food and Drug Administration (FDA) have issued a Class I Recall of the Medtronic Neuromodulation INDURA IP, consisting of 2 models of intrathecal catheter, the suturless pump, and the intrathecal catheter pump segment revision kit.

A Class I Recall is the most serious of type of product recall issued by the FDA, and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death.

The intrathecal catheter or intrathecal catheter revision kits use a sutureless connector for the final connection to the implanted Medtronic SyncroMed II, SynchroMed EL, and IsoMed infusion pumps. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space.

This recall was prompted by potential misconnections of the Medtronic sutureless connector ("SC") 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.

The product models included in the recall are: Intrathecal Catheter, Model 8709SC; Intrathecal Catheter, Model 8731SC; Sutureless Pump; Connector Revision Kit, Model 8678; and Intrathecal Catheter Pump Segment Revision Kit, Model 8596SC.

OCT-02-08: FDA Issues Recall of Medtronic Infusion Pump [FDA: MEDTRONIC INDURA IP RECALL]

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Published on Oct-2-08