Medtronic Infusion Pumps Recalled
October 8, 2008 by Bob Christensen
Serious Risk for Life-Threatening Blockages
Medtronic and the Food and Drug Administration (FDA) have issued a Class I Recall of the Medtronic Neuromodulation INDURA IP. Class I Recall’s are the most serious of type of product recall issued by the FDA, involving situations in which there is a reasonable probability that use of the product will cause serious injury or death. This recall consists of 2 models of Medtronic intrathecal catheters, the suturless pump, and the intrathecal catheter pump segment revision kit.
Medtronic has sold around 25,000 of the catheters involved in this recall which 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. To date, the improper connections between implanted catheters and pumps that deliver infused drugs have been detected in 83 patients. One patient has died.
The specific model numbers releated to this recall are:
- Indura 1P Intrathecal Catheter, model 8709SC
- Intrathecal Catheter, model 8731SC
- Sutureless Pump Connector Revision Kit, model 8578
- Intrathecal Catheter Pump Segment Revision Kit, model 8596SC
If you have had a procedure in which one of these pumps were used, I can answer questions regarding your legal rights. Don’t hesitate to contact me via email or call 612.333.7733.
