Medtronic Infusion Pump Recalled by the FDA

Medtronic and the Food and Drug Administration (FDA) issued a Class I Recall of the Medtronic Neuromodulation INDURA IP. The recall of the Medtronic device was prompted by potential for life-threatening blockages.
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 pain pumps are often used in patients who have spasticity related to cystic fibrosis, traumatic brain injury, multiple sclerosis and chronic pain. About 25,000 devices have been sold since May 2007.
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 Medtronic Neuromodulation INDURA IP consists of 2 models of intrathecal catheter, the sutureless pump, and the intrathecal catheter pump segment revision kit.
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.
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.
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