Medtronic, Inc.
FDA Classifies Medtronic's Notification Related to Improper Connection of Sutureless Intrathecal Catheters as a Class I Recall
Published in Medical Letter on the CDC and FDA, October 19th, 2008
Medtronic, Inc. (NYSE:MDT) announced that the U.S. Food and Drug Administration (FDA) has classified its safety alert about the proper connection of sutureless catheters used with implantable drug infusion systems as a Class I recall. The notification relates to the improper connection of its sutureless connector intrathecal catheters (referred to as SC catheters). The affected products include the following models; INDURA 1P Intrathecal Catheter, model 8709SC, Intrathecal Catheter, model 8731SC, Sutureless Pump Connector Revision Kit, model 8578, and Intrathecal Catheter Pump Segment Revision Kit, model 8596SC.
In June 2008, Medtronic informed the FDA and clinicians...
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