FDAnews
www.fdanews.com/articles/120781-medtronic-recalls-intrathecal-catheter-connector-kit

Medtronic Recalls Intrathecal Catheter, Connector Kit

September 25, 2009
Medtronic is recalling two intrathecal catheters, a sutureless pump connector revision kit and its intrathecal catheter pump segment revision kit, an action the FDA considers a Class I recall. Labeling incorrectly says the catheters are intended to be used with Medtronic’s IsoMed constant-flow infusion pumps. A physical interference between the catheter connector and the IsoMed pump prevents the catheter from completely connecting to the pump, which could result in disconnection or a blockage at the connection site, according to an FDA statement.