FDA MedWatch

 

Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit- Class I Recall

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.

Read the entire 2008 MedWatch Safety Summary, including a link to the FDA Class I Recall Notice regarding the above issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#INDURA