Recall Z-1574-2013— Medtronic Neuromodulation

Class I FDA medical device recall by Medtronic Neuromodulation, initiated 2013-06-03, terminated 2014-04-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strain-relief sleeves, Connector pin. Contents of inner package are STERILE. The Medtronic Model 8596SC Pump Segment Revision Kit is used when a revision to the pump segment of the Model 8731 or Model 8731SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and a Model 8731 or Model 8731SC catheter. The catheter connects to the pump at the catheter port.. Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion..

Recalling firm

Medtronic Neuromodulation

Classification

Class I

Status

Terminated

Initiated

2013-06-03

Terminated

2014-04-07

Firm location

Minneapolis, MN, United States

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