Skip to main content
Drug Injury Lawyer 24/7

FDA Drug & Medical Device Recall News & Comments 
Thursday, September 24 2009

Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit

Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service managers

FDA notified healthcare professionals of the Class 1 recall of Medtronic SC Catheters and Revision Kit Models: 8709SC, 8731SC, 8578, and 8596SC when paired with the Medtronic IsoMed Pump Model 8472, due to a design incompatibility resulting in a physical interference between the SC catheter connector and the IsoMed pump. This may prevent the SC catheter from completely connecting to the IsoMed pump, even though it may appear to be connected and feel secure and may lead to disruptions of therapy and revision surgery, which pose a risk of serious injury or death.

SC catheters are not compatible with IsoMed pumps but are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. To date, Medtronic has received ten reports worldwide related to improper connection of an SC catheter to an IsoMed pump.  In all ten reports, medical intervention was required to correct the condition. Medtronic has provided recommendations in their Medical Device Correction Letter (see link in FDA Recall Notice). 

Read the complete MedWatch 2009 Safety summary, including a link to the Class 1 recall notice, at:
Posted by: DW AT 11:21 am   |  Permalink   |  Email
Willis Law Firm - Houston, Texas Drug Injury Lawyer and Attorney Free Lawsuit & Class Action Lawsuit Lawyer




This is an Attorney / Lawyer Advertising Website. It is not a medical information, medical dictionary, medical advice or medical help site. Talk to you own treating Doctor about any questions or concerns that you have concerning any medicine, drug, medical device or treatment plan. Do not rely on any information on this site to alter, stop or change any medication or treatment plan by your prescribing or treating Doctor. Many of the drugs and devices listed here on this site have published risk and warnings associated with their use and have not been recalled. This website is not in anyway connected with any drug company or the FDA.Check with your Doctor, Pharmacy and/or the FDA as to any concerns as to their use, recall status and safety. See for the latest information.

Principal Office -Willis Law Firm 5005 Riverway Drive, Suite #160 Houston, Texas 77056